Careers 2018-11-09T14:21:40+00:00

About icon large

We have a vacancy for a Pharmaceutical Development Director.

Blueberry’s vision is to bring high value, innovative medicines to the market that make a real difference to patients’ lives. We are now growing, and looking for a part time Pharmaceutical Development Director to join our successful team. If you have the skills listed below, enjoy working in a dynamic, exciting environment, and really want to have a positive impact on patients’ lives, then we’d love to hear from you.


Pharmaceutical Development Director

This role will be 2-3 days/week with the scope and flexibility to develop into a full-time position.

Key duties will include:

  • Lead pharmaceutical development projects across our early and late stage programs, in partnership with CMOs/CROs
  • Build and maintain effective, positive working relationships with CMOs/CROs
  • Work with the Chief Scientific Officer, senior team and external partners to build fully integrated project plans; developing manufacturing strategies and related activities to deliver new products for early clinical testing through to commercial-readiness
  • Proactively manage projects to identify issues in timing, resources and funding to prevent delays in project milestones. Including providing solutions for issues and development of risk mitigation plans
  • Assist the Financial Director and senior team with the forecasting and management of pharmaceutical development budgets.
  • Work with regulatory leads and CROs to support pharmaceutical development planning for regulatory filings worldwide, including licensing applications
  • Work with Preclinical team to develop strategies for advanced forms, using a Quality by Design approach
  • Write and review documents for INDs/regulatory section submissions and represent the company as the pharmaceutical development expert before U.S. and European regulatory authorities
  • Prepare, review and edit cGMP batch records, CMC Regulatory and Quality documents
  • Prepare technical reports, publications and oral presentations

The knowledge, skills and abilities we are looking for:

Essential:

  • PhD or MS in Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, or related scientific discipline
  • At least 5 years’ relevant experience in a pharmaceutical or biotechnology pharmaceutical development/cGMP environment
  • Background in drug formulation, ideally topical, including CMC and clinical drug supply
  • Proven experience in building relationships and managing collaborations with external CMOs/CROs
  • A team player with strong project management skills
  • Experienced with cGMP manufacturing and IND, CTA and NDA filings; thorough knowledge of relevant FDA and EMEA regulations
  • Good communication skills, both written and oral

Desired:

  • Experience in supply chain management
  • Able to identify and resolve critical issues
  • Flexibility and the willingness to get involved with other activities that support the development of our drug programs
  • Experience in implementing technical, strategic and operational plans

To apply for this role, please email Susie at susan.yau@blueberrytherapeutics.com with your covering letter and CV.

Applications will be reviewed on an ongoing basis. Once sufficient suitable applications have been received, the recruitment window will close.

To recruitment companies: Blueberry Therapeutics will not be accepting applications or CVs via recruiters. Any unsolicited emails, phone calls or CVs will not be acknowledged.


0
Drugs in our pipeline
0
Patents and exclusives licences
0
Billion dollars in commercial potential

T: 01625 238776
E: info@blueberrytherapeutics.com

Blueberry Therapeutics Ltd
Blueberry Therapeutics, Mereside, Alderley Park, Alderley Edge, Cheshire, SK10 4TG.