Senior Manager/Associate Director of Clinical Manufacturing Plant

This is not your “everyday” manufacturing opportunity -- in this new and important role, your savvy business acumen and expertise in cGMP biologic manufacturing will help facilitate 4D’s road to a pivotal point in its history – a fully integrated biopharmaceutical company with cGMP clinical manufacturing and future commercial facility. 

Reporting to the VP of Manufacturing/Supply Chain, you will manage & establish cGMP clinical pilot manufacturing plant operation and be a key driver to design, build, and commission state-of-the-art gene therapy clinical manufacturing plant. You will lead/manage cGMP pilot manufacturing and assist in quality, compliance and safety programs in line within defined timelines for the daily manufacturing operations of biologic products to support gene therapy clinical trial and product development. In addition, you will drive the implementation of process improvements/scale-up and liaise between various functional teams to ensure our cutting-edge gene therapy products are supplied of the highest quality and on schedule.  You bring deep understanding of biologic manufacturing (API/DS background is preferred), Quality, Planning and Regulatory processes.  The icing on the cake – coupling your cGMP biologic manufacturing expertise with the most cutting-edge science in gene therapy!

Responsibilities

• Manage supervisors/associates responsible for GMP production. Provide hands-on person-in-plant oversight and training as needed and ensure the operation within the pilot plant is conducted under current safety and cGMP guidelines.  Ensure that plant operations SOPs are followed, batch records are adhered to, and that log books for room and equipment utilization are kept current with appropriate records.
• Manage production scheduling, including upstream, downstream, and fill/finish, coordinating with PD, QA, Analytical Sciences, and clinical development teams. Manage all aspects of GMP production, ensuring timely supply of raw materials, media/buffer, single use consumables and equipment spare parts, etc. to support the needs of each pilot manufacturing area. Maintain appropriate order records for audit purposes.
• Train scientists/engineers/associates on various process equipment and procedures. Coordinate third party/outside vendor trainings as necessary.  
• Lead the reporting, investigation and resolution of deviations encountered during GMP production activities, working with manufacturing compliance and QA groups.  Provide sufficient/regular training to ensure clinical batch records are complete with minimal documentation error and other deviations, and that the process deviation is investigated and complete in a timely manner following quality SOPs.
• Work with Process Development on a routine basis to ensure accuracy of tech transfer documentation to establish and execute batch records from solution prep, upstream cell culture, downstream purification, to fill finish operation. Guide manufacturing team to complete campaign report. Support scale-up and initiatives for new technology development and continuous improvement projects.
• Author, edit, and review master batch records based on tech transfer report, standard operating procedures, change controls, deviation reports, memos, and protocols/reports.
• Work with material management to ensure the ongoing security of the supply chain for raw materials and intermediates to assure the uninterrupted performance of vector production operations and provision of material for clinical programs; minimize downtime for utility & facility related to equipment failure, spare parts, calibration or related issues. 
• Work with manufacturing support group/outside cleaning groups to supervise the cleaning crew to ensure facility is in good and appropriate condition for GMP manufacturing.
• Actively provide hands-on support for initial pilot plant facility commissioning, equipment qualification, start-up and operation for biopharmaceutical drug substance production. Work with engineering firm for manufacturing plant design/commissioning/qualification/ validation, and for material/instrument planning, crucial for initial operation for existing and future pilot plant.
• Work collaboratively with integrated CMC teams and support IND filings as related to clinical manufacture to advance Company goals.
• Ensures project deadlines and quality standards are established and met.

Qualifications

• BS or MS in bioprocessing, chemical engineering, or biology with at least 10 (manager) to 15 years (sr. manager and associate director) of cGMP manufacturing experience in biopharmaceutical industry.  
• Strong experience in the biotechnology or pharma industry with a primary focus on upstream cell culture (including disposable single-use bioreactor systems), transfection, downstream processing (including AKTA systems and Unicorn software), and fill finish operations for viral vectors and/or biologics. Specific experience with AAVs is desirable.
• Experience with large scalable processes for production of biologics including adherent and suspension bioreactor and downstream purification; drug product experience a plus.
• Ability to work independently or with minimal oversight; strong interpersonal skills, a collaborator/ team player, open minded to the diverse opinions of others; experience managing both people and projects; excellent communication skills, both written and verbal.
• Excellent time management skills (schedules, timelines, task prioritization) and the ability to multi-task and adapt to changing priorities. Ability to thrive and succeed in a team-oriented entrepreneurial environment.
• Current understanding and application of best practices related to process hygiene/microbial control, equipment cleaning, and change-over procedures.
• Background in equipment qualification (IQ/OQ/PQ) a plus.
• Ability to lift at least 25 lbs.

We are 4D Molecular Therapeutics (4DMT) -- a global leader in gene therapy product research & development using scientific innovation to unlock the full potential of gene therapy for patients with genetic diseases. Our goal is to design and develop transformative gene therapy products using our proprietary adeno-associated virus variants platform to treat serious unmet medical conditions.  

While AAV gene therapy pioneers are making great strides with the first wave of products, hurdles still exist with the use of 1st & 2nd generation vectors (naturally occurring primitive viral capsids).  4DMT’s next-generation Therapeutic Vector Evolution platform generates targeted, optimized and proprietary AAV vectors that have the potential to overcome the delivery and immunological challenges currently facing the field, ultimately unlocking the full potential of gene therapy.

We invite all of you who share our passion and vision in creating the ultimate gene therapy products to cure severe genetic and rare diseases with high unmet medical need.  We seek the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers uniquely generous benefits and provides challenging opportunities for career development.