Overview
Job Summary: Oversees the Manufacturing group, which includes Process Development, Technical Transfer, and Operations. Responsible for the operation of a state of the art Cell Therapy facility. Works closely with the groups' Associate Directors and Area Management to ensure day-to-day MFG operations are performed within Minaris Advanced Therapies Quality standards. Maintains rigorous quality mindset and advocates strict adherence to compliance practices within the department and the facility. Possesses rigorous scientific skills in the specific science area and a strong working knowledge of the technical and current Good Manufacturing Practice (cGMP) compliance requirements for manufacture of biologics. Specific responsibilities include specifying equipment, identification and development of Standard Operating Procedures (SOPs) and Master Batch Records, commissioning and validation as well as staffing and training of the Manufacturing group to be competent in current Good Manufacturing Practices (cGMP). Interacts with Engineering, Maintenance, Validation, Quality Assurance, Facilities, Quality Control, Materials Management groups, and material/equipment vendors and commercial partners.
Responsibilities
Essential Job Functions:
Prepares / approves process specific protocols, Policies, and Standard Operating Procedures (SOPs).
Ensures MFG schedule is maintained assuring customer timelines remain intact.
Supervises, plans and reviews operations for assigned staff, including responsibility for training, managing and evaluating as well as coordinating, scheduling and assigning work and maintaining standards.
Evaluates / Recommends hire / transfer / promotion / discharge and salary changes and acts on employee problems.
Conducts employee performance appraisals in a timely and objective manner.
Interacts with clients to discuss project planning and requirements
Prepare proposals for MFG programs
Design production schemes and process improvements
Interpretation of MFG PD and /or verification run results
Provides strong in-house guidance on science and technology.
Interacts with internal staff to identify areas for improvement or development and oversees improvement efforts.
Travels with other Minaris Advance Therapies staff to visit clients / vendors as appropriate.
Presents technical seminars at external professional meetings as appropriate.
Accomplishes staff results by communicating updated organizational information, job expectations & supporting their work
Plans, monitors, and appraises direct reports including performance competencies, goals & job results
Coaches, counsels, and conducts disciplinary actions
Develops, coordinates, and follows organizational systems, policies, procedures, and follows labor and capacity standards
Contributes to the overall operations and to the achievement of departmental goals
Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
Other duties as assigned
May be required to assist in other departments
Qualifications
Experience / Education
10 or more years of relevant experience or equivalent
Bachelors' degree with a major in Biological Sciences or other science related field or equivalent experience
Knowledge / Skills / Abilities:
Knowledge of cGMP guidelines is required .
Ability to make decisions based on a wide knowledge of factors where application of advanced or technical concepts is predominantly required.
Ability to evaluate technical data and write technical documents.
Ability to use judgment as dictated by complexity of situation.
Ability to work under limited supervision and to handle problems of a difficult nature.
Ability to accomplish the described duties through the use of appropriate laboratory equipment (i.e. biohazard hood, centrifuge, incubator, and autoclave) and computer equipment and software. (i.e. Microsoft Word, Outlook).
Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
Ability to record data accurately and legibly.
Ability to understand and follow verbal or demonstrated instructions.
Ability to express or exchange ideas by means of the spoken word.
Ability to work effectively as part of a team and to exhibit effective interpersonal skills.
Ability to receive and comprehend and to effectively communicate detailed information through verbal and written communication.
Proficient in Oral & Written communication skills
Need to be able to read, write and understand English
Proficient in Microsoft (Excel, Word, Outlook)
Physical Requirements:
Must be able to work in an office environment with minimal noise conditions.
Must be able to work in Lab setting with Biohazards /various Chemicals
Must be able to wear appropriate PPE
Must be able to work in environment with variable noise levels
Ability to stand /Sit/walk for long periods of time
Clarity of Vision
Ability to identify and distinguish colors
Must be able to perform activities with repetitive motions
Ability to climb Ladders / Stairs / Scaffolding
Ability to work in variable temperatures high to freezing
Inside/outside working conditions
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
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Job Locations US-PA-Philadelphia
Job ID 2025-13671
