Careers

Job Description

This position reports to the Vice President of Operations.

The Sterile Drug - 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.

Essential functions and 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.

Minimum qualifications shall 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 from you:

• Appropriate professional demeanor.
• 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.

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.

Job Details

McGuff Pharmaceuticals, Inc. in Santa Ana, CA is looking for a Biopharmaceutical Quality/Validation Technician in Santa Ana, CA.

The Quality/Validation Technician (QT) will work closely with the Quality Engineering and Validation Supervisor to plan, organize and perform commissioning, qualification and validation for defined processes, facilities, equipment and process controls that meet McGuff Pharmaceutical’s high standards. The Technician will maintain the existing manufacturing facility by maintaining the calibration program and periodic review/requalification program.

The QVT will develop, plan, coordinate and execute qualification projects associated with drug product sterile contract manufacturing, aseptic processing, filling, and packaging. The Technician shall be familiar with the qualification of facilities, pharmaceutical manufacturing equipment/systems, sterilization processes, sterile filling processes, cleaning processes, environmental room monitoring, media fills, and process validation runs. The Technician will be capable of executing equipment IQ/OQ/PQ and process validations as required. In addition, the Technician 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 Technician 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 Technician shall ensure McGuff processes are compliant with cGMP requirements.

Essential functions and duties shall include:

• Maintain the validation program for computer systems, facilities, equipment, manufacturing processes in an aseptic filling facility by coordinating, performing and scheduling requalifications and periodic reviews per the validation program.
• Maintain the calibration program by identifying and assessing instrumentation and scheduling periodic calibration activities.
• Develop and document written qualification/validation protocols and reports.
• Perform and assist with qualification / validation protocols for projects in compliance with McGuff policies and procedures and industry guidelines in the performance of, such as, IQ/OQ/PQ and other validation activities.
• Coordinate, perform and schedule calibration activities

• Perform various testing procedures as needed for process inputs, outputs and parameters, such as, temperature monitoring, TOC analysis, LAL (Endotoxin), environmental monitoring, bioburden testing, sterility testing, chemical analysis, physical analysis, etc… according to written procedures (SOPs).
• Develop and document written SOPs, as required, for current Good Manufacturing Practices (cGMP).
• Implement document changes and control procedures.
• Conduct QA investigations and follow-up
• Prepare and document procedures and protocols, including commercial batch record preparation and review.
• 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:

• 2 year technical degree required. Bachelor’s degree (B.A./B.S.) of Science in Engineering, Chemistry or related field or equivalent is a plus.
• Prefer minimum of 1-2 years relevant Pharmaceutical/Biotechnology 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.
• In addition to the minimum requirements, the preferred candidate will have experience in the pharmaceutical manufacturing industry (aseptic fill, small volume, sterile, injectable products), and experience in technical presentations and report writing. Certifications preferred (e.g. ASQ CQE or CRE).

Interested candidates you must please email us at employment.mpi@mcguff.com with the subject line reading “McGuff Careers: QEV Technician” 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, 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.