Sr Analytical R&D Manager
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POST DATE 9/1/2016
END DATE 12/19/2016
Pharmaceutical R&D company
POSITION TITLE: SR ANALYTICAL R&D MANAGER (PHARMA)
LOCATION: RALEIGH - DURHAM, NC AREA
POSITION TYPE: STAFF POSITION WITH EXCELLENT BENEFITS & BONUS POTENTIAL
SALARY: $80 - $100K, D.O.E.
POSITION NUMBER: 9105
Our Client is a major contract pharmaceutical R&D company, leading the field in development, formulation, analysis, and testing, as well as clinical supply manufacturing. They have asked Hallmark to help them find their next Senior Analytical R&D Manager. This position reports to the Director of In Vitro Sciences, and will manage a team of scientists in the research and development of in vitro release testing.
This role is a staff position with a great career path and excellent benefits, including Medical, Dental, Vision, HSA, Life/AD&D, Disability and Retirement coverage.
* Oversight and execution of methods development and validation of in vitro release testing methods for semi-solids, and transfer of HPLC assay methods
* Act as liaison between formulation R&D and the in vitro release testing team, providing data interpretation and input on formulation design and optimization
* Write validation and transfer protocols, instrument qualification protocols, validation/qualification reports, SOPs, etc.
* Manage multiple projects simultaneously, communicating with study sponsors and R&D business partners
* Supervise, mentor, train and develop junior scientists
* Lead, review and trend laboratory investigations from aberrant data, system suitability failures, method/protocol deviations, and OOS/OOT results, and implementing CAPA for such occurrences
* Coordinate with R&D departments to optimize resources, streamline laboratory functions and operations, and improve quality
* Coordinate with QA department to identify, initiate and implement corrective / preventive actions
* Maintain a GMP-compliant analytical laboratory, and safe working environment
EXPERIENCE AND SKILLS:
* Ph.D. with 3years of related experience in pharmaceutical sciences, chemistry, or related discipline **OR** M.S. with 5years of related experience
* Proven track record developing and validating analytical methods
* Prior experience in a GMP / CMC environment of topical product development / semi-solid formulations, as well as CRO experience
* Experience developing and validating assay methods using HPLC
* Previous contract R&D experience is preferred
* Experience with in vitro release testing for semi-solid products is preferred
* Working knowledge of regulatory requirements, including cGMP, FDA, CFRs, ICH and USP
* Innovative thinking and good decision making abilities, displaying sound judgement and strong analytical skills
* Strong assessment / problem solving skills, able to take action and adapt as needed
* Excellent verbal and written communication skills, including active listening and the ability to present information in a logical, professional, and articulate manner
* Skill in MS Office (Word, Excel, PowerPoint, Outlook), and Adobe Acrobat
Hallmark and our Client are Affirmative Action, Equal Opportunity Employers. We encourage all qualified people with the current right to work for any employer in the USA to apply. Principals only, please.