Senior Director, Clinical Manufacturing Operations
Our client is a global manufacturing company. They have asked us to assist them in their search for a Senior Director, Clinical Manufacturing Operations.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Oversees day-to-day clinical manufacturing and collaborates with all enabling functions to ensure high-level first time-right and adherent to schedule.
- Collaborates closely with process development teams to ensure speedy and reliable technical transfer to fulfill clients’ business demands such as IND and clinical supply.
- Collaborates with development functions to perform needed process characterization and performance qualification (PPQ) at scale.
- Champions the efforts from clinical manufacturing to manage clients’ complaints through close collaboration with project management.
- Prepares and approves process specific protocols, Policies, and Standard Operating Procedures (SOPs).
- Ensures manufacturing 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.
- Conducts employee performance appraisals in a timely and objective manner.
- Interacts with clients to discuss project planning and requirements.
- Reviews and recommends execution content for proposals for manufacturing programs.
- Designs production schemes and process improvements.
- Interprets 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 delivering performance efficiencies to impact departmental gross margin.
- Prepares and reports key performance measures weekly, quarterly, and annually.
- Drives startup operations for new facilities through technical and organizational leadership from the Manufacturing lens to keep the project on schedule and within budget.
- Drives financial performance of department through industrial efficiency, human capital management and greater utilization of physical assets.
- Specifies equipment, identification, and development of Standard Operating Procedures (SOPs) and Master Batch Records.
- Is responsible for commissioning and validation as well as staffing and training of the Manufacturing group to be competent in cGMP.
- Interacts with Engineering, Maintenance, Validation, Quality Assurance, Quality Control, Materials Management groups, and material/equipment vendors and commercial partners.
- Accomplishes staff results by communicating updated organizational information, job expectations and supporting their work.
- Plans, monitors, and appraises direct reports including performance competencies, goals, and job results.
- Coaches, counsels, and conducts disciplinary actions.
- Develops, coordinates, and follows organizational systems, policies, procedures, and follows labor and capacity standards.
- Requires a master’s degree or PhD, or a bachelor’s degree with at least 15 years of relevant technical experience and a minimum of 5 years managing people.
- Prior experience in technical development strongly preferred.
- Knowledge in cell and gene therapies or biologics manufacturing is required.
- Knowledge in cell and gene therapies or biologics technical development strongly preferred.
- Knowledge of cGMP guidelines is required.
- Must understand clinical lifecycle from preclinical through late stage and early commercialization.
- Ability to make decisions based on a wide knowledge of factors where application of advanced or technical concepts is predominantly is required.
- Requires the ability to evaluate technical data and write technical documents.
- The ability to use judgment as dictated by complexity of situation is required.
- Requires the ability to work under limited supervision and to handle problems of a difficult nature.
- Must have the ability to accomplish the described duties using appropriate laboratory equipment and computer equipment and software.
- Requires the ability to perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations accurately and reproducibly.
- The ability to record data accurately and legibly is required.
- Must be able to work in Lab setting with biohazards/various chemicals.
- Must be able to understand and follow verbal or demonstrated instructions.
- The ability to express or exchange ideas by means of the spoken word is required.
- Requires the ability to work effectively as part of a team and to exhibit effective interpersonal skills.
- Must be able to receive and comprehend and to effectively communicate detailed information through verbal and written communication.
- 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 an environment with variable noise levels.
- The ability to stand/sit/walk for long periods of time is required.
- Clarity of vision is required.
- The ability to identify and distinguish colors is required.
- Must be able to perform activities with repetitive motions.
- Requires the ability to climb ladders/stairs/scaffolding.
- Requires the ability to work in variable temperatures high to freezing.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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