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Director of Process Development

3 months ago

Philadelphia, United States Scout Bio Full time

**ABOUT THE COMPANY**

Our world-class team of human and animal health biotechnology veterans has an enviable track record of success, and now we're looking for a Director of Process Development to join our growing, international team.

Join us and play a key role in bringing gene therapy and cutting-edge therapeutic proteins to veterinary medicine, to improve the quality of life for companion animals and their owners.

Our labs are based in the historic Curtis Building in beautiful Old City, Philadelphia. We also have teams in Europe and Australia.

**ABOUT THE ROLE**

Reporting to the Vice President, Chemistry, Manufacturing and Controls (CMC), this new role will be based at our labs in Philadelphia or in reasonable proximity for frequent travel to Philadelphia for meetings.

You will work with Contract Manufacturing Organizations on some process development activities.

You will be responsible for managing the CDMO’s that are authoring the CMC technical sections and answering technical questions from the regulators.

If we decide to build out our internal team and internalize our process scale-up and development activities, this role with take the lead on building this team and infrastructure.

**Key duties**

**Research Programs**
- Advise on the selection of cell lines and platforms at an early stage to ensure that the material we use for research is scalable.
- Identify and manage CDMO’s for early material supply.
- Manage our internal laboratory team to produce material for early material supply for pharmacokinetic (PK) and proof-of-concept studies.

**Development Programs**
- Work with external service providers to ensure the delivery of projects according to the relevant mAb and AAV processes.
- Manage technical transfer and scale-up of our manufacturing processes into the CDMO GMP production facilities.
- Review and approve batch manufacturing records, SOPs, and other quality system documentation to support GMP manufacture with our CDMO partners.
- Lead the analytical development activities to support process development and process characterization studies.
- Provide expert input into our process validation program, including viral validation studies, cleaning validation, leachable studies, column and membrane reuse studies, and process characterization.
- Lead the writing of relevant sections of the Common Technical Documents (CTD) to support our regulatory submissions.
- Work closely with specialist contract testing service providers to ensure the successful execution of all deliverables.
- Identify equipment requirements and work with vendors to ensure execution of all deliverables including equipment qualification and validation.
- Provide technical reports on the completion of development and validation tasks.
- Participate in Quality and Safety regulatory audits.

**Future opportunities**
- Develop and build out a laboratory team that transitions from small-scale material supply to registration batch manufacture.
- Participate in due diligence on external licensing opportunities.

**ABOUT YOU**

You will have:

- Skills, knowledge and experience_
- BSc, MSC, PhD in a relevant discipline (e.g. biochemistry, chemistry, process engineering) or equivalent experience.
- At least 10 to 15+ years of relevant experience in bioprocess development and/or manufacturing. Human health applicants are encouraged to apply.
- Relevant experience in a comparable role and proven track record of success.

Pay: $180,000.00 - $240,000.00 per year

**Benefits**:

- 401(k)
- Dental insurance
- Employee assistance program
- Health insurance
- Paid time off
- Vision insurance

Schedule:

- Monday to Friday

Application Question(s):

- Briefly describe your experience in a comparable position elsewhere, that makes you eligible for consideration for this role.

Work Location: Hybrid remote in Philadelphia, PA 19106