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 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

We are an innovative, fast-paced team that is advancing a diverse array of cutting-edge translational research projects. At Theradaptive, you will experience the challenge and satisfaction of the therapeutic product development process firsthand, bridging both Biologics and Device fields. Transform your career and join the Theradaptive team today!

POSITION SUMMARY:

We are seeking a talented Manager/Sr. Manager of Manufacturing Science and Technology (MSAT) to be part of our growing team. The MSAT Manager will have primary responsibility in support of manufacturing process development to ensure manufacturability, transfer of processes into Contract Manufacturers, supporting manufacturing campaigns and CMC activities. They will report to the VP of Manufacturing.

The ideal candidate will have expertise in cGMP manufacturing, scale-up, and technology transfer for recombinant proteins. Experience in combination drug/device is a bonus. The MSAT Manager will have primary responsibility in support of manufacturing process development to ensure manufacturability, transfer of processes into Contract Manufacturers, supporting manufacturing campaigns and CMC activities. The MSAT Manager will also be responsible for building the MSAT team, establishing the necessary system to support product transfers, and data analytics to ensure successful process execution.

RESPONSIBILITIES:

• Work closely with R&D team to assure process reliability and robustness in preparation for transfer to manufacturing and future scale-up and process validation and support team in Design review activities
• Support manufacturing operations at CMOs – Biological and combination product
• Anticipate and proactively resolve key technical scale-up related issues
• Evaluate risk appropriately and communicate effectively and in a timely manner.
• Ensure timely review and completion of technical documentation (Technology Transfer documents, batch records, SOPs, protocols & reports)
• Supports investigations at CMOs.
• Prepare technical reports to summarize data and document experimental conclusions and manufacturing campaign conclusions.
• Participate in evaluation of new technology, raw materials qualification for introduction into cGMP manufacturing for Phase I and Phase II products.
• Partner with 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.
• Execute experiments as needed to support production – Fermentation, Purification and Combination Device Development
• Partner with Quality Organization to ensure compliance at CMOs.
• Communicate project status, roadblocks and results to supervisors and managers

QUALIFICATIONS:

• Bachelor’s degree in Chemical Engineering, Bioengineering, Biomedical Engineering, Chemistry, Biology, or a related field. Master’s degree is beneficial.
• 5-8 years of relevant biopharmaceutical or combination product manufacturing, technology transfer & process development experience
• Mastery of scientific and engineering principles
• 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
• Experience with standard data analysis tools (Excel, JMP)
• 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
• Ability to travel to contract Manufacturing sites to support production

POSITION LOCATION:

• Theradaptive corporate headquarters and laboratory in Frederick, MD. Travel to Contract Manufacturing Organizations may be required 25% to 50% of the time

• Manufacturing and Manufacturing Science and Technology, Technology Transfer

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.