The Sr. Scientist II is responsible to independently develop, validate and/or evaluate new analytical methods and/or manage these activities for Alvogen’s third party sites using advanced analytical techniques that meet the current regulatory standards. The individual should be well versed in cGMP compliance and UD FDA Regulatory requirements pertaining to analytical methods. The position also involves writing / reviewing documents such as protocols, reports, investigations, change controls and CMC Regulatory submissions and responses.
The Senior Scientist II reports to the Director, Analytical Development or designee.
- 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.
- MS in Chemistry, Biochemistry or related discipline with 8+ years of experience or PhD with 5+ years of experience in generic pharmaceutical industry.
- Experienced in analytical characterization of various dosage forms including but not limited to Oral, Topicals, Transdermal, Sublingual and Parenteral dosage forms 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.
GMP DECISION-MAKING AUTHORITY
This position has the GMP decision-making authority, including but not limited to method validation protocol and reports, laboratory investigations, establishing specifications for APIs, excipients and finished products, stability protocols and reports.
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