Manager, External R&D and Technical Services
Proclinical is currently recruiting for a Manager of External R&D and Technical Services with a pharmaceutical company located in Montville, NJ. Successful candidate will be responsible to independently develop, validate and/or evaluate new analytical methods and/or manage these activities for the company's third-party sites using advanced analytical techniques that meet the current regulatory standards.
- Acts as an analytical SME for 3rd party product development using traditional and advanced analytical techniques including but not limited to HPLC, GC, Dissolution, IVRT, LC-MSMS, GC-MS, XRPD, Raman, FTIR, Microscopy, PSD, Viscosity, SEC etc.
- Applies in-depth knowledge and expertise in the authoring or review of various protocols / reports including but not limited to development, validation and laboratory investigations. Conclude root cause and CAPA review.
- Independently perform "hands-on" experiments and complex tasks such as methods development, unknown impurity identification, elemental impurities, material characterization and reverse engineering studies.
- Interact with internal partners, CMOs and contract laboratories during the technology transfers of analytical methods, clinical batch testing, stability testing and CMC compilation of assigned projects.
- Contributes in review / authoring of CMC section ANDA filings and is a major contributor to providing scientifically sound responses to FDA deficiency letters.
- Reviews / authors protocols, reports and technical documents in support of product development and filing.
- Interprets complex data and solves scientifically challenging problems by providing direction and leadership in the AR&D Laboratory.
Skills and Requirements:
- Bachelor or MS in Chemistry, Biochemistry or related discipline with 5+ years of experience or PhD with 3+ years of experience in the pharmaceutical industry.
- Experienced in analytical characterization of various dosage forms including but not limited to Oral, Topicals, Transdermal, Sublingual and Parenteral dosage form products.
- Job involves lab work, understanding of cGxP, CMC, ICH and compendial (USP/EP/JP) regulatory requirements.
- A strong commitment to experimental work is essential, as well as the ability to independently identify and solve complex problems to advance projects through the development process.
- Strong analytical, organizational and communication skills.
- Job involves some travel.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Brandy Plumb at (+1) 646-367-2745 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
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.