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.
We are seeking a talented Director/Associate Director, Analytical Development. The successful candidate will be responsible for building and leading the Analytical Development team by hiring members at different levels, equipment selection, advancing analytical method development, and qualification and transfer for Theradaptive’s pipeline programs. This individual will oversee a combined Analytical Development and Quality Control team. As a team leader, this individual will be responsible for the implementation of methods, including transfer and bridging, for use in Quality Control testing of GMP and in development testing of PD/R&D samples. This individual will be responsible for developing analytical testing strategies for Biologic Drug Substances and Drug Product/Medical Devices including justifying specifications based on data and statistical analysis, in-process and release assays, and stability testing.
This individual will demonstrate a thorough knowledge and understanding of technologies required to implement new analytical methods and define analytical control strategies by applying Quality by Design principles and Design Control strategies. As the Analytical Development team lead, this individual will also help establish and lead through the initial establishment of Quality Control for qualification, bridging and routine testing activities. The selected individual will have working knowledge and application of US and EU regulatory requirements, regulatory expectations, and compliance. As part of a dynamic fast paced and growing organization, the successful candidate will have the ability to adapt to the needs of an innovative and collaborative environment.
If you are driven to contribute in an exciting and dynamic environment, we encourage you to apply now!
- Lead Analytical Development and product characterization for Theradaptive’s recombinant proteins, medical devices, bio-scaffolds, etc.
- Define stage appropriate analytical testing strategy towards development of robust and validation ready analytical methods, including evaluation of suitability of existing methods and developing new methods.
- Take responsibility for Analytical Development and Quality Control from laboratory set-up to implementation of regulatory compliant systems, including method qualification, bridging and transfers.
- Foster a data integrity mindset within the Analytical Development/Quality Control team. Develop and implement regulatory and quality system compliant documentation including drafting quality policies, SOP’s, test records associated with testing.
- Support OOS and deviation management through providing technical guidance and resolution of issues arising during testing.
- Remain up to date with advanced technical knowledge of analytical methods from external sources and implementing within the teams.
- Develop procedures and approaches that assure the highest scientific rigor and analytical approach.
- Collaborate with cross functional teams to prepare for product specific development of analytical methods.
- Contribute to the preparation of regulatory filings.
- Travel to CRO/CDMO sites within USA/internationally may be required.
- Ph.D. or master’s degree in Biochemistry, Pharmaceutical Analysis, Biotechnology, or Analytical Chemistry.
- 10-15 years of experience in leading analytical method development and interacting directly with GMP Quality Control for biologics.
- Experience of implementing advanced analytical methods for protein characterization including cell-based assays and immuno-assays is required. Expertise in cell-based assays, ELISA’s, SPR, etc. is required.
- Knowledge of analytical instrumentation such as HPLC, Mass Spectrometry, CE-SDS, cIEF, etc. is required.
- Experience in implementing analytical methods for polymers, detergents, excipient characterization is a plus.
- Understanding of regulatory requirements for CMC product development is required.
- Experience in leading teams with diverse skills and mentoring technical staff.
- Strong scientific and analytical thinking skills.
- Understanding of compendial assays including microbiological assays and environmental monitoring techniques.
- Experience in implementing ICH guideline-based stability studies and development methodologies.
- Demonstrated teamwork across departments including research and development functions.
- Ability to work in a laboratory and office setting.
- Ability to lift up to 40 lbs.
- Ability to work in a laboratory with chemicals and biochemicals and perform Biosafety Level 2 work
- Theradaptive corporate headquarters and laboratory in Frederick, MD. Travel to CRO/CDMO may be required 10% of the time.
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.