Theradaptive is revolutionizing the field of therapeutic delivery with a pipeline of best-in-class products that address multiple global markets. Theradaptive is performing cutting edge science in the area of regenerative medicine, working at the interface of Biology and Orthopedic tissue repair.
Our lead therapeutics are in the following indications:

• Spinal Fusion
• Long Bone Repair
• Osteochondral Repair
• Dental and Facial Bone Repair
• Immuno-Oncology

We are an innovative, fast-paced team that is advancing a diverse array of cutting-edge translational research projects.
POSITION SUMMARY:

We are seeking a talented Associate Director of Manufacturing to be part of our growing team. The Associate Director will have primary responsibility for establishing our internal cGMP manufacturing capability as well as managing production at our partner CMO’s. The position will report directly to the VP of Manufacturing and will work hand in hand with Quality, QC/AD, Clinical/ Regulatory, Materials, MSAT and PM to ensure high quality cGMP product is delivered on time and in full.

The ideal candidate will have expertise in cGMP manufacturing ramp - clinical to commercial, facility build-out, start-up and validation. Demonstrated ability in building a high-performance production team is a must. Experience in biologics and/or device manufacturing is preferred. The candidate will be detail-oriented and have a proven ability to multi-task and pivot quickly based on project priorities. Excellent interpersonal skills and the ability to work well with internal and external staff at all levels are essential to this role.

If you are driven to contribute in a highly dynamic environment, we encourage you to apply now!RESPONSIBILITIES:

• Assist in facility design and build-out, equipment selection and generation of necessary SOP’s/documentation to support facility startup and operation.
• Build, train and maintain a high-performance manufacturing team.
• Support manufacturing operations at CMOs – Biological and combination device product to ensure material supply meets Clinical demand.
• Partner with Quality Organization to ensure compliance internally and at CMOs.
• Anticipate and resolve key technical or Quality issues.
• Lead/Support any non-conformance investigations as needed.
• Ensure timely review and completion of batch documentation (batch records, SOPs, protocols & reports).
• Work closely with R&D and MSAT team to assure process reliability and robustness in preparation for transfer to manufacturing and future scale-up and process validation.
• Participate in evaluation of new technology, raw materials qualification for introduction into cGMP manufacturing for Phase I and Phase II products.
• Partner with MSAT and CMOs to ensure facility fit - appropriate equipment capability and identify changes needed in the process development or at the manufacturing site to enable facility fit.
• Communicate project status, roadblocks, and manufacturing results to Project Team.

QUALIFICATIONS:

• Bachelor’s degree in Chemical Engineering, Bioengineering, Biomedical Engineering, Chemistry, Biology, or a related field preferred.
• 8 years of relevant biopharmaceutical or combination product manufacturing,
• 5 years of progressive leadership experience
• Practical expertise with cGMP manufacturing and regulatory requirements for pharmaceuticals and/or devices.
• Solid experience with fermentation and purification
• Experience in process validation.
• Ability to think critically, and demonstrated troubleshooting and problem-solving skills
• Excellent interpersonal, verbal, and written communication skills
• Self-motivated and willing to accept temporary responsibilities outside of initial job description.
• Ability to function efficiently and independently in a changing environment
• Proficiency in MS Office (Word, PowerPoint, Excel)

PHYSICAL DEMANDS:

• Ability to work in a GMP manufacturing environment – Biologics and Combination Device manufacturing
• Ability to work in a laboratory with chemicals and biochemicals and perform Biosafety Level 2 work

POSITION LOCATION:

• Maryland/DC Beltway: 100% of the time will be required to be in Maryland at the Theradaptive Laboratories in Frederick
• Ability to Travel, domestic and international, to support partner CMO’s

DEPARTMENT:

• Manufacturing

https://www.theradaptive.com
Theradaptive is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, ethnic or national origin, ancestry, pregnancy (including childbirth or related condition), citizenship, familial status, mental or physical disability, veteran status, genetic information, other non-disqualifying disability, or any other characteristic protected by law.