Senior Scientist, Formulation Process Development

Senior Scientist, Formulation Process Development - Permanent - Onsite

Proclinical Staffing is seeking a Senior Scientist, Formulation Process Development to join a clinical-stage pharmaceutical company. This is a permanent role located in Newark, CA.

Primary Responsibilities

We are seeking an experienced individual to provide scientific, technical and hands-on support of parenteral pharmaceutical development and manufacturing. The qualified candidate will support technical leads for late-stage drug product development, including technical contributions to process validation, drug product manufacturing, and global regulatory documentation.

Skills & Requirements:

• Experienced in late-stage process and formulation development of sterile, parenteral dosage forms (pre-filled syringe and lyophilized products)
• Experienced in writing and reviewing technical documentation for GMP activities and process validation at partnering CMOs, such as master batch records, executed batch records, risk assessments, process characterization protocols and reports, change controls, and master validation plans, protocols, and reports
• Experienced in writing and reviewing drug product technical sections for global regulatory submissions, such as IND, IMPD, and NDA
• Experienced in person-in-plant responsibilities for technical and quality support of GMP operations
• Excellent communication skills (both verbal and technical) and interpersonal skills are required
• Experience in parenteral formulation development and manufacturing, late-stage development required
• Experience with peptides preferred, small molecule or biologics also acceptable
• PhD with +5 years industry experience, MSc with +8 years industry experience; degree in Pharmaceutical Sciences or related field
• Demonstrates excellent writing and communication skills.

The Senior Scientist, Formulation Process Development will:

• Technical reviewer and author for NDA-readiness activities related to parenteral drug products
• Works with internal and external quality control, quality assurance, and regulatory personnel to resolve technical issues or procedural deviations
• Presents results of work, interprets data, and draws conclusions for sterile drug product manufacturing process development, characterization, and validation
• Thinks critically and creatively and can work independently, with particular focus on attention to detail and knowledge of regulatory and quality requirements for aseptic processes
• Serves as person in plant during clinical trial material manufacturing and/or critical process development experiments. Ability to travel domestically and internationally is expected, approximately 20% of work time.

Compensation:

$145,000 annually

If you are having difficulty in applying or if you have any questions, please contact Jessika Rodriguez at (+1) 617-391-0929 or j.rodriguez@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

INDSCIC