Manager, Clinical and Regulatory Affairs

WHO WE ARE:

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

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

Theradaptive is honored to be recognized as one of Maryland’s Future 20 Start-up Companies, an elite group of innovative start-ups with the “potential to be the state’s next major business success story.” https://commerce.maryland.gov/media/governor-hogan-announces-marylands-future-20-startup-companies 

POSITION SUMMARY:

We are seeking a proactive, enthusiastic, and independent Manufacturing Manager with expertise in cGMP manufacturing, scale-up, and technology transfer for recombinant proteins. The Manufacturing 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 individual may be based remotely or in the DC Beltway/Maryland area. This position will interact with all parts of the organization including Research and Development, Analytical Development, Regulatory and Quality. Knowledge of fermentation, purification and support systems, and its associated bioprocessing equipment used in the manufacturing of biotech products is a necessary skill set.

Our ideal candidate will possess a breadth of knowledge and creativity and will be highly motivated. 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 is an important skill set needed to succeed in this role.

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

RESPONSIBILITIES:

• Support manufacturing operations at CMOs – Biological and combination product
• Anticipates and resolves key technical scale-up related issues, to ensure manufacturing process and equipment set is capable of performing as required. Evaluates risk appropriately and communicates effectively and timely.
• Understands critical process parameters.
• Ensure timely review and completion of technical documentation (Technology Transfer documents, batch records, SOPs, protocols & reports)
• Supports investigations at CMOs.
• 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.
• 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.
• Support the Research and Development Team
• Execute experiments – Fermentation, Purification and Combination Device Development
• Partner with Research and Development to design experiments and implement plans with minimal guidance.
• Propose viable solutions to technical problems and make educated recommendations for next steps
• Prepare technical reports to summarize data and document experimental conclusions and manufacturing campaign conclusions.
• 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.
• 3-5 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

POSITION LOCATION:

• Maryland/DC Beltway or Remote: 25% to 50% of the time may be required to be in Maryland at the Theradaptive Laboratories or at a Contract Manufacturing Organization.

DEPARTMENT:

• 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.