Senior Scientist - Senior Engineer - Biopharma
Located in Bend, OR
Salary: Excellent comp & benefits!
Who We Are!
Our client is a clinical-stage biopharmaceutical company specializing in the development of innovative drug therapies to improve the lives of patients with metabolic and orphan diseases. The company’s pipeline includes three programs comprised of two clinical stage compounds and one late pre-clinical stage platform. We are seeking highly qualified and dynamic individual to join and help grow our emerging biopharma company.
Where You Get to Live!
Bend, Oregon is the mountain town that has it all! Located in the in the shadows of the Cascade Mountains and surrounded by numerous lakes and rivers, Central Oregon is an outdoor enthusiast’s paradise. Check out the sights and sounds of Bend at: https://vimeo.com/200038114
What You Get to Do!
The Senior Scientist role will be responsible for Product Development and CMC-related activities across the portfolio which includes; defining fundamental biological and chemical process approaches, manufacturing oversight, pre-formulation, formulation, stability assessments, and supply of clinical trial materials. The ideal candidate will be highly flexible and motivated with interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities.
• Demonstrate expert technical knowledge in pharmaceutical drug development
• Review analytical data packages for accuracy and completeness
• Work with and manage Contract Development and Manufacture Organizations (CDMOs) to execute product development activities which enable both large and small molecule from pre-clinical to Phase 3 registration studies
• Select robust, scalable and cost-effective manufacturing routes and drug product formulations that meet or exceed the target clinical profile
• Design and implement strategies for optimizing and controlling the quality of bulk Active Pharmaceutical Ingredient (API), Drug Substance (DS) and Drug Product (DP) using an external CDMO, laboratory and consulting network
• Project API, DS and DP needs for preclinical and clinical programs (with the clinical team), and associated budgets (with finance team)
• Oversight and integration of supply chain and logistics in support of the product development plan and associated clinical studies
• In coordination with Quality Control and Quality Assurance, implement stage appropriate analytical methods and protocols while ensuring that all CDMO’S are using systems and processes in compliance with all relevant regulatory standards
• Coordinate with team members to write and reviewing documents for INDs / regulatory section submissions
• Work closely with Quality Assurance and Operations management to prepare, review or edit cGMP batch records, CMC regulatory and Quality documents to include change controls, deviations, investigation, standard operating procedures, and forms as necessary to advance the pipeline or a specific program
• Prepare technical reports, publications, and oral presentations
What You Will Need:
• BS or MS with 5+ years of experience with a focus in Biology, Chemistry, Pharmaceutical Science, or related scientific discipline preferred
• Knowledge of solid state and chemical analytical characterization of small molecules; alternately extensive knowledge in biochemical analytical characterization of proteins, mAbs, fragments, and biologics
• Basic Understanding of organic chemistry to evaluate crystalline API synthesis
• Capable to recommend appropriate drug product formulation approaches using API chemical properties
• Experience with projects in clinical development e.g. Phase 1 through Phase 3 including multiple pharmaceutical dosage forms (e.g. tablets, capsules, solutions, etc.)
• Experience in managing CDMO’s for the development and manufacture of cGMP APIs and DP
• Experience with cGMP manufacturing and IND, CTA and NDA filings; knowledge of relevant FDA and EMEA regulations
• Exposure to supply chain management
• Able to work independently while quickly identifying and resolving critical issues
• Experience implementing technical, strategic and operational plans
• Excellent written and verbal communication skills, exceptional interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators)
• Good humor, agility in learning and action, and a team player
To Apply: For confidential consideration, please submit resume to: firstname.lastname@example.org
Express Office: Bend
61379 South Highway 97
Bend, OR 97702