Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.
Post: Senior Manager - Analytical R&D
Job Description:
* Accountable and responsible to guide team members for development and validation of analytical methods ( robust and cost effective) for drug substances and drug products using basic and high end analytical instrumentation including genotoxic impurities and degradation products
* Plan and monitor stability programs running In house and at CRO’s (Exploratory and Registration ) as per VMRD / VICH guidelines
* Participate and contribute scientifically for drafting specifications for DS and DP at various stages of development activities
* Ensure successful completion of analytical tech transfers to respective manufacturing locations across the globe in a timely manner.
* Participate and contribute to drafting and completion of analytical sections for CMC dossier for filing.
* Ensure timely responses to regulatory queries during pre and post approval stages
* Present analytical updates (Scientific /Strategic) to leadership team, co development forums, Pharm Sci teams and Analytical sub teams via telecons and/ or during meetings.
* Liaise, lead, co-ordinate activities running at CRO’s.
* Contribute in bringing new vendors by being actively involved as analytical expert on board for outsourcing work as and when deemed appropriate
* Lead and participate in recruiting ,hiring scientists for analytical and other lines as and when required
* Prepare proposals; ensure requisite approvals for infrastructure /manpower required for analytical function from time to time.
* Prepare and Revise SOP’s and Guidelines as and when required.
* Ensure compliance to SOP’s (Safety, Laboratory work, Quality) in analytical operations
* Ensure effective utilization of resources to work within committed budgets , track and publish key metrics from time to time
* Coach/lead team members , support objectives setting, performance evaluations( midyear and Annual), monitoring team goals , IDP discussions and ensure all related tasks (objectives entered, help to identify needs for training courses and development of new skills, etc.) are performed as per organization guidance from time to time
* Proactively participate in budget forecast, procurement as and when required.
* Participate and actively ensure collaboration with various groups within and outside of Pfizer
Job Summary:
Provide leadership to a team of analytical scientists for ongoing projects to ensure timelines and deliverables are met as per organization expectations.
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Candidate Profile:
Minimum Skills and Competencies:
* Expert in the use of analytical instrumentation including HPLC, GC, LC-MS, Dissolution, Spectroscopy and/or Solid State techniques (DSC,TGA,DVS,pXRD,etc.)
* Advanced computer skills in LIMS, chromatography data acquisition systems and MS Office software.
* Thorough understanding of development activities and processes in pharmaceutical industry
* Ability to work in and/or lead interdisciplinary and/or cross-cultural teams.
* Proven leadership ,coaching and mentoring skills
* Strong knowledge of cGMP, cGLP, VICH and EHS guidelines
* Self Motivated individual with excellent communication, presentation and scientific/technical writing skills
* Candidate must be able to quickly adapt to changing project needs, assignments and environments.
* Recognize issues, make effective plans, prioritize ,get resources in place to achieve targets
* Good project management, time management, and decision making skills.
Qualifications and Experience:
M.Sc./ M.Pharm./ Ph.D (Analytical chemistry /Pharmaceutical Chemistry) with 12-15 years of experience out of which minimum 5 years of direct experience in demonstrating successful leadership of teams working on multidisciplinary projects in a multicultural environment in Analytical R&D of a reputed Pharmaceutical Company
Additional Information:
Experience: Min. 5 Years
Location: Thane
Education: M.Sc./ M.Pharm./ Ph.D
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: R&D
Job ID: 964917
LAST DATE: 23rd May, 2012
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