At McGuff, we attract and recruit the finest people in the world. Whenever possible, we build our organization from within, promoting and rewarding people with regard only to performance. When internal candidates are unavailable or we search for candidates with different qualifications we search for the most qualified candidates from outside the organization.
McGuff values its employees as a key resource. An atmosphere of good employee communication, involvement and responsibility is of central importance. Employee’s personal development and optimum use of talents is encouraged.
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:
Minimum qualifications shall include:
What is expected from you:
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:
Minimum qualifications shall include:
What will be expected of you:
Physical requirements:
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 3rd 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:
Minimum qualifications shall include:
What Is Expected of you:
Physical requirements:
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.
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.
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.
McGuff will do all that is reasonable and practicable to protect the health and safety of its employees.
McGuff will treat its employees as family and will make every effort to maintain healthcare insurance to each employee.
Every employee has equal opportunities and will be treated equally in employment and occupation regardless of personal background, race, gender, nationality, age, sexual preference or religious belief. The same applies to the recruitment of employees. McGuff strives to offer equal pay for equal work performed at equal levels at similar locations. No form of harassment or discrimination will be tolerated.
Remuneration and working hours shall comply with local labor laws and shall at least be in line with prevailing industry norms.
McGuff recognizes the importance of each employee’s contribution to the labors of the company and desires that each employee be compensated in such a manner as to promote long-term employment and retirement benefits.
Expanded coverage, including a confidential employee assistance program
Plan for your future with our 401(k) company contribution plans.
11 vacation days and paid federal holidays
86,000 sq. ft. state-of-the-art, aseptic fill, pharmaceutical manufacturing facility