JobTitle:Director MS&T

Location: Harmans, MD

Summary:

The Manufacturing Sciences and Technology Director will develop and lead a new group to technically support the manufacturing group, including the transfer between external clients or Process Development and Manufacturing. The director is responsible for leading the team of strong engineers and scientists to be technology transfer process owner to deliver excellent services to internal and external customers.

• The position will direct a group of engineers and other direct reports to drive the facility fit and technical transfer of mammalian, microbial, Gene and Cell Therapy and viral vector biologic processes, including the evaluation, alignment and recommendation of equipment/process improvements.
• This role will also support on-the-floor technical support to manufacturing.
• The director will be responsible for supporting the preparation and review of documentation, compiling and analyzing of process data, and provide technical input in the deviation investigation, change controls, and CAPAs.
• The individual will work closely with Clients, Process Development, Manufacturing, and Quality to ensure successful implementation of cGMP drug substance and drug product manufacturing processes.
• Strategic client facing leader of the MS&T team on the behalf of the organization.
• Leads a team of engineers and scientists responsible for the effective technology transfer of processes into Manufacturing for both internally and externally developed processes.
• Works cross functionally with process development, manufacturing, quality assurance, quality control, supply chain, and facilities departments to effectively transfer and maintain processes in the facility.
• Participates and leads commercial manufacturing transition and support for process development.
• Supports process characterization and validation in preparation for commercialization.
• Leads strategic alignment across Catalent Cell and Gene Therapy sites.
• Lead the evaluation, remediation and optimization of products and processes using statistical tools to ensure safety, quality, delivery and cost standards. Enhance productivity by exploring, analyzing, facilitating and leveraging efficiency initiatives for manufacturing processes.
• Ensure that changes to existing processes or the introduction of new processes are carried out and documented according to approved change control procedures and in compliance with cGMP requirements.
• Bridge the focus areas of R&D, Quality, EHS, Production, Supply Chain and Engineering to create common understanding and objectives and ensure robust products and flawless manufacturing.
• Works closely with manufacturing to provide on-the-floor technical oversight through each product campaign startup as well as in response to any process/equipment troubleshooting requirements.
• Leads the compilation of process data, including communicating project status, and delivering internal and client presentations.
• Collects and trend process data for external (Clients) and internal review to ensure process consistency.
• Evaluates existing processes and identifies process and/or equipment improvement to improve efficiency, consistency, and competitiveness within the market. This includes development of project requirements, feasibility, and technical design for implementation into cGMP environment.
• Provides business case for process improvement projects
• Authors and reviews technical reports, process tech transfer summary reports, master batch records, product and equipment specifications, and protocols in support of tech transfer and cGMP activities.
• Acts as the lead for technical support deviations, change controls, and CAPAs including determination of event impact, root-cause analysis, and corrective action identification.
• Responsible for maintaining a high performing team by hiring, training, motivating, evaluating, and developing staff.

Education:

• PhD in Biotechnology, Chemical or Pharmaceutical Engineering, or related field, with minimum of 8 years of relevant experience; orM.S./M.A. in Biotechnology, Chemical or Pharmaceutical Engineering, or related field, with minimum of 12 years of relevant experience; or B.S./B.A. in Biotechnology, Chemical or Pharmaceutical Engineering, or related field, with minimum of 14 years of relevant experience.
• Experience with Upstream and Downstream processes at the small to intermediate scale of cGMP biologics production Prior experience in process scaling and technology transfer is required.
• Advanced project management experience/skills required including method transfers, and risk assessment.
• Knowledge of regulatory, validation and documentation requirements for product development, commercial production and site transfers.
• Experience in report and documentation skills
• Experience in investigating and closing out deviations, OOS, CAPAs, and change controls
• Experience writing and revising standard operating procedures and batch production records
• Experience with operating and troubleshooting process equipment Experience working on late phase and commercial programs is a plus

Technical Requirements:

• Ability to use Excel, Word, and other office systems, as well as programs for multiple pieces of manufacturing equipment.
• Ability to peer review data to ensure data is well organized with complete documentation.
• Ability to independently interpret data, analyze trends and provide insight into potential issues and subsequent solutions.
• Ability to problem solve to initiate and execute/monitor corrective action.
• Ability to write SOPs, batch production records and reports independently.
• Strong technical knowledge in operation and troubleshooting of a wide variety of equipment and data systems.
• Ability to work with and lead other groups to develop, qualify and transfer methods, and drive complete investigation, deviation, and change control practices.
• Strong technical knowledge and hands-on experience with biological manufacturing and validation concepts and procedures in a cGMP environment.
• Ability to provide ideas, introduce new technology, and drive process improvements.
• Work with other groups to develop, qualify and transfer methods accordingly.
• Strong interpersonal and presentation skills to discuss technical concepts internally and with clients.
• Ability to learn and use software packages (e.g. TrackWise®, ComplianceWire®).
• Demonstrated strong working knowledge of Tech Transfer (Internal and External) between Development and Manufacturing.
• Demonstrated understanding of multiple applicable techniques, including: purification, buffer preparation, chromatography and filtration, operation and troubleshooting of stirred vessel bioreactors, incubators, chromatography columns, and filtration apparatus.
• Understanding and application of Risk Assessment tools (Hazard Analysis, FMEA, etc.).
• Ability to formulate complex and comprehensive materials such as authoritative reports and/or to create/deliver formal and informal presentations.Ability to write, edit and review SOPs and reports with guidance.
• Can effectively back-up supervisor to address technical or business issues.
• Provides reliable / defendable interpretations of regulatory guidance for the customer and is capable of defending these positions to regulatory agencies.

Behavioral Requirements:

• Ability to see and hear, read and write clear English.
• Requires adaptability, analyzing, assessing, calculating, decision making, dependability, good judgment, reading, memorizing, social skills, speaking, stress control, writing.
• Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary, in a professional and accurate manner.
• Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time.
• Ability to cooperate with coworkers within an organized team environment or work alone.
• Detail oriented with ability to work effectively under high pressure with multiple deadlines.
• Ability to effectively carry out and implement change.
• Ability to put aside personal opinions and focus on business needs, department needs or group needs.
• Ability to understand opposing points of view on highly complex issues and to negotiate and integrate different viewpoints.
• Ability to transfer knowledge to others via training or mentoring of staff; demonstrated ability to guide others through communication and learning.
• Ability to make decisions which have significant impact on the department’s credibility, operations, and services.

Leadership Requirements:

• Ability to manage and develop a high profile group within the Harmans, MD site
• Ability to organize and prioritize work schedules of others, including integrating timelines and meeting milestones for successful project completion.
• Demonstrated ability to lead by influence and drive results through others not under direct supervision.
• Safety and Environmental Requirements:
• Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening.
• Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities for the position.
• Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures must be followed to minimize exposure, including proper use of PPE (personal protective equipment) and clean room gowning.
• Working conditions will be Heating Ventilation and Air Conditioned controlled.

Business Environment:

• Fast-paced
• Performance driven
• Customer focused
• Collaborative and inclusive
• Team player

Physical Requirements:

• Individual may be required sit for extended periods Occasionally lift up to 40 pounds
• Be accessible to manufacturing floor and office staff and to use required office equipment
• Specific vision requirements include reading of written documents and frequent use of computer monitor

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.