Careers

Job Details

McGuff Pharmaceuticals, Inc. in Santa Ana, CA is looking for a Project Management Lead that will develop, plan, direct and control projects associated with drug product manufacturing, aseptic processing, filling and packaging. They will oversee all aspects of projects by working directly with management and internal support teams. The Project Manager will manage project timelines by setting milestones and assigning tasks as well as monitor and summarize project progress. They should possess a broad range of skills in process analysis, project planning, coordination, and project execution.  They will be tasked to develop, optimize and maintain the project plan to complete qualification, validation and FDA approval of a new startup Pharmaceutical Manufacturing facility. 

Essential functions and duties shall include:

• Define overall project initiatives as defined by company leadership
• Review/develop/revise/update the Project Plan, Integrated Master Schedules and Gantt Chart
• Identify project teams, develop project plans and timelines, manage project budgets and costs, and conduct routine project meetings.
• Closely follow-up with projects to ensure project deliverables are met.
• Identify Project tasks and their description, sequence, interaction, dependencies, resource and skill requirements, in-process status, completion time and resource time requirement estimates.
• Define existing project resource quantity, availability, qualifications and capacity.
• Determine Critical Path, Work Breakdown Structure, Project Task List, Project Task Calendar, Project Cost Schedules, Project Variance to Plan, Schedule and Budget, Earned Value Management metrics.
• Conduct routine project meetings and generate meeting minutes and action items.
• Assist in developing scope of work for drug product manufacturing projects and technical transfer.
• Manage project teams with strong communication and interpersonal relationship skills to ensure project objectives and milestones are reached.
• Direct and coordinate the activities of internal cross-functional project team members such as Engineering, Purchasing, Quality Assurance, Quality Engineering, Validation, Manufacturing and Maintenance, demonstrating a strong ability to function well in a team environment.
• Responsible for the entire project lifecycle including project initiation, planning, execution, monitoring and closing

Minimum qualifications shall include:

• Education: Bachelor of Science degree in Information Technology, Engineering, Chemistry or Biology and a minimum of 3 years of experience in managing large-scale complex projects in a technical field.
• Minimum of 3 years relevant Pharmaceutical or Medical Device Industry project management experience dealing with Plant Startups, FDA/GMP Approval, Prior Approval Supplements, Abbreviated New Drug Applications, Equipment, Plant and Process Qualification and Validation, Capital projects
• PMP Certification highly desired, CAPM, ACP, RMP, SP, PgMP Certification a plus
• Demonstrated Project Management knowledge tools and techniques such as WBS, Gantt, CPM, Pert, EVM, BCWS, PV, BCWS, EV, BCWP, Kanban and SCRUM/Agile.
• Must have strong computer skills with super user expertise in Microsoft Project.
• Experience with MasterControl software a plus.
• Experience with aseptic manufacturing environments, equipment and qualification, URS, FAT and SAT, IQ/OQ/PQ, FMECAs, NDA, ANDA, PAS, Automation, Commissioning, Validation Master Plan, Site Master Pla
• Familiarity with related GMP procedures and requirements. Including knowledge of appropriate Quality Systems and cGMP requirements (FDA, EU, ICH) with the ability to assess compliance risks.Must be a self-starter with the aptitude to work independently and use good judgment while performing multiple tasks.
• Analytical skills: capable of identifying problems quickly and finding the underlying causes so changes can be documented, effectively implemented and verified.
• Versed in the proper use of statistical techniques and sampling plans.
• Excellent oral and written communication skills. Must be able to relay potentially complex ideas to a wide range of audiences – both in personal consultations but also through company communication systems, presentations, graphical summaries, reports and/or dashboards.
• Ability to manage multiple concurrent tasks / studies / projects
• Type a minimum of 45 words per minute.

What is expected of you:

• Capable of motivating others over whom no direct supervisory authority exists in a dynamic and fast-pace environment. Ability to shift and change priorities as needed.  Well developed motivational and influencing skills to elicit cooperation and performance of technical resources.
• Strong leadership skills, capable of using good reason and judgment to, make, defend and uphold decisions and recommendations.
• Acquire knowledge of and assure compliance to corporate policies and procedures.
• Ability to work with others.
• Excellent communication skills.
• Work with all McGuff employees to foster and promote quality.
• Excellent customer skills
• High regard for Trust, Integrity, Honesty, Ethics, Innovations and Safety in self and others.
• High sense of Responsibility, Ownership, Accountability.
• Capable of Flexibility in work requirements/conditions and willingness to embrace change
• Results driven.

Physical Requirements: 

• Position requires bending, squatting, climbing, and reaching above shoulder level. You must be able to comfortably be able to do so.
• Position requires sitting, standing, walking, handling and manipulating objects (manual dexterity and fine finger movement).
• Position will require repetitively lifting/carrying up to 75 pounds.

Interested candidates you must please email us at employment.mpi@mcguff.com with the subject line reading “McGuff Careers: Project Management Lead” with a copy of your most updated resume attached (cover letter optional).

Salary: Dependent on Experience/Background.

Job Details
McGuff Pharmaceuticals, Inc. currently has an opening for a Production or Facilities Technician to work the 3^rd Shift (9pm-6am), Monday through Friday OR Thursday through Monday, within our aseptic fill and finish contract manufacturing facility located in Santa Ana/Costa Mesa, CA. This position reports to the Plant Manager.

Entry level candidates are welcome. Preferred candidates will be familiar with pharmaceutical production, and have one to three years experience in related pharmaceutical/pharmacy activities.

This Technician must be detail-oriented, results-oriented, possess good communication and writing skills, capable of performing assigned production duties and flexible in adapting to changing work priorities.

Essential functions and duties shall include:

• Operation of pharmaceutical manufacturing equipment including automated aseptic fill lines, washers, ovens, and autoclaves
• Troubleshooting, Preventive Maintenance (PM), Corrective Maintenance (CM), Clean-in-place (CIP), Steam-in-place (SIP) or pharmaceutical equipment
• Facility maintenance and repair
• Janitorial duties as needed.
• Responsible for set-up, adjustments, sanitation, minor maintenance, and operation of all machinery in the sterile filling area
• Experience in using aseptic technique to conduct aseptic filtration and filling of finished product when needed
• Knowledge of current Good Manufacturing Practices (cGMP) guidelines
• Capable of following standard operating procedures (SOP’s) in performing tasks
• Responsible for supply of components into processing areas
• Compounding of bulk solutions
• Accurate completion of production documentation and all appropriate log books.
• Other duties as assigned (e.g. may include material stocking and assisting Engineering and the on-sight laboratories in various projects as assigned).
  

Minimum qualifications shall include:

• Must have graduated high school or obtained G.E.D. equivalent
• Must be able to work 3rd shift rotation from the hours 9pm-6am, Monday thru Friday OR Thursday thru Monday
  

What Is Expected of you:

• Appropriate professional demeanor.
• Ability to work well with others.
• Possess excellent communication skills.
• Work with all McGuff employees to foster and promote quality.
• High regard for Trust, Integrity, Honesty, Ethics, Innovations and Safety in self and others.
• High sense of Responsibility, Ownership, Accountability.
• Capable of Flexibility in work requirements/conditions and willingness to embrace change
• Results driven and a hands on approach to completion of assigned tasks

Physical requirements:

• Position requires bending, squatting, climbing, and reaching above shoulder level. You must be able to comfortably be able to do so.
• Position requires sitting, standing, walking, handling and manipulating objects (manual dexterity and fine finger movement).
• Position will require repetitively lifting/carrying up to 50 pounds and manipulating upwards of 200 lb.

Interested candidates you must please email us at employment.mpi@mcguff.com with the subject line reading “McGuff Careers: 3rd Shift Technician” with a copy of your most updated resume attached (cover letter optional).

Salary: Dependent on Experience/Background.

McGuff Pharmaceuticals, Inc. (a subsidiary of McGuff Company, Inc.) is a licensed pharmaceutical manufacturer, FDA registered company with a reputation for outstanding commitment to quality and customer satisfaction.

As a dedicated member of the healthcare community, we have openings for individuals willing to work in a dynamic and challenging environment that is sure to provide opportunities for personal growth and development. Join us as we continue our quest to improve our products, quality systems, and facilities to exceed customer expectations.

Job Details:

The Pharmaceutical Product Development Manager will oversee and be responsible for all cGMP Sterile Drug Engineering, Manufacturing and Facilities. A subject matter expert. Identifying product development candidates and, in turn, managing all Product Development projects and activities for McGuff Pharmaceuticals sterile injectable products produced, primarily through Aseptic manufacturing processes. Identify and recommend products for development that meet strategic objectives for McGuff Pharmaceuticals, Inc. Develop, implement and continuously improve the product development processes for the organization.

Ensure written procedures and other documents exist for appropriate development activities. Executes tasks related to the company’s product development protocols and ensures formulation and process development activities as well as product transfer and support. Provides technical insight, guidance, and coaches product development staff in areas such as product selection, safety, project planning, product research, product/process development and application, and analytical techniques. Manage the product development projects, as assigned, with regards to materials, equipment, operating procedures and compliance to company policies. Interfaces with other departments as needed to progress projects. Helps to manage and facilitate information flow including product development records, literature, intellectual property and relevant documentation. He/she will work closely with key opinion leaders (KOLs), customers, company personnel and company management to ensure all applicable policies and procedures, state and federal laws, and ICH requirements are met.

Duties shall include:

• Responsible for coordinating and implementing activities related to future and ongoing product development including:
• Implementing departmental policies, programs and procedures for product development.
• Identify and present for senior management review candidate products for development based on market and company capability measures.
• Plan, organize and lead product development projects; including identifying goals, objectives, methods, resources, and routes of communication needed to carry out responsibilities and dates for completion of product development activities and tasks.
• Organizing resources to achieve the goals in an optimum fashion.
• Establishing effective communications and guiding a project teams to accomplish stated project objectives.
• Coordinating and managing assigned product development and engineering activities.
• Meeting strategic objectives for company growth.
• Process and Product Development for targeted products to ensure finished products meet the required safety, identity, strength, quality and purity they purport to possess. This includes developing and defining material specifications, process input specifications, process parameter specifications, process output specifications, product specifications, procedures, and controls.
• Provides technical guidance to department staff as required in areas related to product development such as characterization, pre-formulation, formulation and process development, scale-up, preparing clinical supplies, technology transfer, manufacturing scale-up, and formulation and process improvement.
• Troubleshooting, failure analysis and corrective action of design and processing errors
• Working with Manufacturing, Quality Systems and other personnel to ensure anticipated product development activities and outputs are planned and effectively executed.
• Coordinating product and process engineering, qualification, and validation studies as needed.
• Assurance that product development activities comply with all regulatory and compliance requirements (e.g. NDA, ANDA, IND requirements)
• Working with Key Opinion Leaders (KOLs), customers and clients to define and implement contract manufacturing opportunities to meet customer requirements and exceed expectations.
• Working with customers and other employees to develop, implement and control clinical trials.
• Other duties as assigned.

Qualifications include:

• Education: Bachelor of Science in Engineering or related field degree. Advanced technical degree is a plus: MBA, Masters of Science, or PhD Degree.
• Minimum of 10 years relevant industry experience. Prefer minimum of 7 years relevant pharmaceutical industry experience with a portion of that experience in product development of sterile injectable drugs produced by aseptic processes.
• Experience with regulated industry Product Development and Regulatory requirements.
• Familiar with Chemistry, Engineering and Manufacturing operations.
• Knowledge of state, federal, and international regulatory requirements and submissions (Federal marketing application such as NDA, ANA, IND, PMA, etc…) for Pharmaceutical (or medical device) products.
• Thorough understanding and application of technical principles, theories, and concepts related to product, process, technology development and evaluation.
• Understanding and working knowledge of chemical and physical properties of pharmaceutical active ingredients and excipients as they relate to formulation, process and drug delivery.
• Working and theoretical knowledge of pharmaceutical ingredients, manufacturing, processing and testing equipment, advanced technologies, and delivery systems.
• Ability to develop formulations, processes, and pharmaceutical products.
• Working understanding of statistical techniques including experimental design.
• Knowledge of FDA and International Conference on Harmonization (ICH) guidance affecting drug product development (e.g. FDA Patient‐Focused
• Drug Development Guidance, ICH Q1 to ICH Q14, etc…)
• Knowledge of FDA requirements and guidance (e.g. new product development, cGMP and marketing applications)
• Computer literate and familiar with computerized inventory monitoring, tracking and control systems.
• Type a minimum of 45 words per minute.

What is expected?

• Appropriate professional demeanor.
• Actively take effort in business development.
• Actively part take in the growing and continuous efforts of staff development
• Lead and manage others by exemplary leadership and mentorship.
• Supervisory responsibilities.
• Acquire knowledge of and assure compliance to corporate policies and procedures.
• Ability to work with others.

Interested candidates you must please email us at employment.mpi@mcguff.com with the subject line reading “McGuff Careers: PD Manager” with a copy of your most updated resume attached (cover letter optional).

Salary: Dependent on Experience/Background.

McGuff Pharmaceuticals, Inc. (a subsidiary of McGuff Company, Inc.) is a licensed, FDA registered pharmaceutical manufacturing company with a reputation for outstanding commitment to quality and customer satisfaction.

As a dedicated member of the healthcare community, we have openings for individuals willing to work in a dynamic and challenging environment that is sure to provide opportunities for personal growth and development. Join us as we continue our quest to improve our products, quality systems, and facility to exceed customer expectations.

Job Details:

McGuff Pharmaceuticals, Inc. currently has full-time openings for a BioPharmaceutical Senior Process Engineer within our Manufacturing Engineering group located in Santa Ana, CA. This position reports directly to the Plant Manager.

The Senior Process Engineer will work with the Plant Manager to develop and optimize processes as well as execute tech, facilities and equipment transfers and scale-up, oversee and be responsible for assigned Engineering projects for McGuff Pharmaceuticals. Responsibilities extend to all activities related to facility expansion, Manufacturing equipment/process design, commissioning, installation, maintenance on equipment, capital, and drive process efficiency while adhering, creating, updating and enforcing Standard Operating Procedures in cGMP. support process development and optimization, manufacturing line support, equipment development, tooling, process transfers and new product commercialization initiatives. The Engineer will also focus on high impact projects that drive continuous improvement in the Santa Ana sterile filling facility.

The Engineer oversee other engineers and technicians and collaborate with cross-functional teams, ensure that all applicable project objectives, policies, procedures, state and federal laws are met.

Essential Functions and Duties shall include:

• Responsible for coordinating and implementing activities related to future and ongoing product development
• Implementing departmental policies, programs and procedures within the engineering group
• Plan, organize and lead engineering projects; including identifying goals, objectives, methods, resources, and routes of communication needed to carry out responsibilities and dates for completion of engineering activities and tasks.
• Organizing resources to achieve the goals within a defined timeline.
• Establishing effective communications and guiding project members to accomplish stated project objectives.
• Meeting strategic objectives for company growth.
• Support both Processes Development and Product Development for generic sterile injectables
• Prepare engineering documentation for equipment procurement (e.g. URS, DDS, FAT, SAT) as well as equipment installs (e.g. IQ, OQ) and process validations (e.g. Cleaning Qualifications, Process Qualifications)
• Develop and define product specifications, procedures, and controls.
• Provide technical guidance to department staff as required in areas related to engineering and process development such as characterization, pre-formulation, formulation and process development, scale-up, preparing clinical supplies, technology transfer, manufacturing scale-up, and formulation and process improvement.
• Troubleshooting, failure analysis and corrective action of design and processing errors
• Working with Manufacturing, Quality Systems and other personnel to ensure anticipated activities and outputs are planned and effectively executed.
• Coordinating product and process engineering, qualification, and validation studies as needed.
• Assurance that product development activities comply with all regulatory and compliance requirements (e.g. NDA, ANDA, IND requirements)
• As assigned by the Plant Manager, working with customers and clients to define and implement contract manufacturing opportunities to meet customer requirements and exceed expectations.
• As assigned by the Plant Manager, working with customers and other employees to develop, implement and control clinical trials.
• Other duties as assigned.

Minimum Qualifications shall include:

• Bachelor’s degree (B.A./B.S.) of Science in Engineering, Chemistry or related field or equivalent; Advanced technical Masters of Science or PhD degree is a plus.
• Minimum of 6 years relevant pharmaceutical industry experience.
• Experience with regulated industry Product Development and Regulatory requirements.
• Familiar with Chemistry, Engineering and Manufacturing operations.
• Knowledge of state, federal, and international regulatory requirements and submissions (Federal marketing application such as NDA, ANDA, IND, PMA, etc…) for Pharmaceutical (or medical device) products.
• Thorough understanding and application of technical principles, theories, and concepts related to product, process, technology development and evaluation.
• Understanding and working knowledge of chemical and physical properties of pharmaceutical active ingredients and excipients as they relate to formulation, process and drug delivery.
• Working and theoretical knowledge of pharmaceutical ingredients, manufacturing, processing and testing equipment, advanced technologies, and delivery systems.
• Ability to develop formulations, processes, and pharmaceutical products.
• Working understanding of statistical techniques including experimental design.
• Knowledge of FDA requirements (cGMP and marketing applications)
• Computer literate and familiar with computerized inventory monitoring, tracking and control systems.
• Type a minimum of 45 words per minute.

What is expected from you?

• Appropriate professional demeanor.
• Acquire knowledge of and assure compliance to corporate policies and procedures.
• Ability to work with others.
• Possess excellent communication skills.
• Work with all McGuff employees to foster and promote quality.
• Excellent customer skills
• High regard for Trust, Integrity, Honesty, Ethics, Innovations and Safety in self and others.
• High sense of Responsibility, Ownership, Accountability.
• Capable of Flexibility in work requirements/conditions and willingness to embrace change
• Results driven and a hands on approach to completion of assigned tasks

Physical Requirements: 

• Position requires bending, squatting, climbing, and reaching above shoulder level. You must be able to comfortably be able to do so.
• Position requires sitting, standing, walking, handling and manipulating objects (manual dexterity and fine finger movement).
• Position will require repetitively lifting/carrying up to 75 pounds.

Interested candidates you must please email us at employment.mpi@mcguff.com with the subject line reading “McGuff Careers: Engineer” with a copy of your most updated resume attached (cover letter optional).

Salary: Dependent on Experience/Background.

Job Details

McGuff Pharmaceuticals, Inc. in Santa Ana, CA is looking for a Biopharmaceutical Quality Engineering and Validation Engineer (QEV) in Santa Ana, CA.

This position is a contract role lasting about 9 - 12 months.

The Engineer will develop, plan, coordinate and execute qualification projects associated with drug product sterile contract manufacturing, aseptic processing, filling, and packaging. The Engineer shall have experience with the qualification of facilities and scale-ups, pharmaceutical manufacturing equipment/systems, sterilization processes, sterile filling processes, cleaning processes, environmental room monitoring, media fills, and process validation runs. The candidate should have experience with single use technology, including sterile filter assembly qualifications. The Quality Engineer will be capable of executing equipment IQ/OQ/PQ and process validations as required. In addition, the Quality Engineer will also assist, in a team based approach, the development and improvement of processes to ensure such processes meet McGuff Pharmaceutical’s high standards of process capability, reliability, and repeatability.

The Quality Engineer will be capable of coordinating and executing process validations and associated system operational needs including, but not limited to, equipment and computer system Installation and Operation Qualifications (IQ/OQ) including temperature mapping, Performance Qualification (PQ) of Utilities, Sterilization and Decontamination Systems, Process Performance Qualification (PPQ), and full process validation documentation. Duties may also include assisting with and evaluating specification development, equipment procurement, operation and maintenance procedure development, and qualifying raw materials, in-process materials and finished goods, as required. The Quality Engineer shall ensure McGuff processes are compliant with cGMP requirements.

Essential functions and duties shall include:

• Ensure manufacturing processes are valid and controlled as implemented.
• Develop and generate written qualification/validation protocols and reports while project deliverables consistently meet established project timelines
• Capable of coordinating and executing all process validations and associated system operational needs including, but not limited to, equipment Installation and Operation Qualifications (IQ/OQ), process Performance Qualification (PQ), full process validation documentation
• Perform various testing procedures as needed for process inputs, outputs and parameters, such as, temperature monitoring, TOC analysis, LAL, environmental monitoring, bioburden testing, sterility testing, chemical analysis, physical analysis, etc… according to written procedures (SOPs).
• Conduct routine project meetings and generate meeting minutes and action items to ensure project objectives and milestones are reached.
• Develop and document written SOPs, as required, for current Good Manufacturing Practices (cGMP).
• Implementing document changes and control procedures.
• Conduct QA investigations and follow-up
• Effectively participate in Quality by Design, continuous improvement initiatives and engineering quality processes.
• Plan, implement, manage and control qualification and validation of manufacturing processes
• Assisting, coordinating, performing and scheduling material qualifications.
• Participate in Risk Analysis (FMECA’s), as assigned
• Assist with process development for targeted products (under a team approach to product/process development).
• Qualification and review of maintenance procedures and schedules for process equipment Troubleshooting and corrective action of processing deviations
• Other duties as assigned.

Minimum qualifications shall include:

• Bachelor’s degree (B.A./B.S.) of Science in Engineering, Chemistry or related field or equivalent; Advanced technical Masters of Science or PhD degree is a plus.
• Minimum of 2 years relevant industry experience in a Quality or Engineering capacity with direct experience in process validation. Prefer minimum of 1-2 years relevant industry experience with a portion of that experience in manufacturing of sterile injectable drugs via aseptic processing.
• Proficient with computers and related software (Microsoft Office Professional)
• Familiarity with related GMP procedures and requirements. Including knowledge of appropriate Quality Systems and cGMP requirements (FDA, EU, ICH) with the ability to assess compliance risks.
• Familiar with data acquisition systems and protocols. Prefer proficiency with specific data acquisitions systems such as Kaye Validator.
• Versed in the proper use of statistical techniques and sampling plans.
• Typing and office based skills
• Excellent oral and written communication skills.
• Ability to work independently and as a team member.
• Ability to manage multiple concurrent tasks / studies.
• High energy, enthusiastic self-starter who can work with minimal supervision.
• Well organized and detail oriented.
• Prefer working knowledge of ISO 9000 requirements.
• Computerized calibration monitoring, tracking and control systems

What will be expected of you:

• Appropriate professional demeanor.
• Acquire knowledge of and assure compliance to corporate policies and procedures.
• Ability to work with others.
• Possess excellent communication skills.
• Work with all McGuff employees to foster and promote quality.
• Excellent customer skills
• High regard for Trust, Integrity, Honesty, Ethics, Innovations and Safety in self and others.
• High sense of Responsibility, Ownership, Accountability.
• Capable of Flexibility in work requirements/conditions and willingness to embrace change
• Results driven and a hands on approach to completion of assigned tasks
• Comply with all McGuff Policies and Procedures

Physical requirements:

• Position requires bending, squatting, climbing, and reaching above shoulder level. You must be able to comfortably be able to do so.
• Position requires sitting, standing, walking, handling and manipulating objects (manual dexterity and fine finger movement).
• Position will require repetitively lifting/carrying up to 50 pounds and manipulating upwards of 200 lb.

Why work for McGuff Family Companies, Inc.?

At McGuff Family Companies, Inc., we offer excellent compensation and benefits programs that reflect our goal to be a competitive and supportive employer. McGuff provides a comprehensive benefits package that includes medical, dental, vision and 401K retirement plans. In addition McGuff values its employee’s and their life outside of work too, which is why we offer all employees 11 paid days off per year!

Not to mention, we are growing fast and new opportunities emerge every day. McGuff offers a supportive setting where you can take control of your career while still enjoying the mentorship to develop new skills in an environment where you have an opportunity to thrive.

Interested candidates you must please email us at employment.mpi@mcguff.com with the subject line reading “McGuff Careers: QEV Engineer” with a copy of your most updated resume attached (cover letter optional).

Salary: Dependent on Experience/Background.