Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. Johnson & Johnson strives to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life. The organization is comprised of more than 250 operating companies with over 127,000 employees located in some 60 countries. With Global sales of USD 71.3 billion in 2013, Johnson & Johnson is recognized as one of the most admired and respected companies in the world. Johnson & Johnson companies are equal opportunity employers.
Post : Manager - Formulation Development
Job Responsibilities
- Responsible in leading development, scale-up and transfer strategy of pharmaceutical new drug products, localization of global products, new line extension of existing marketed products and branded generics ensuring robust formulation and smooth tech transfer to be commercialized in the Indian Market meeting compliance to Regulatory and global standards.
- Ensure and oversee implementation of quality based risk management during development of formulation and process with proper stage wise documentation to justify CMA / CPP to build a robust product at commercial scale.
- Aligning and Issuing documents such as MMR, PCP, PCR, PVP, HTSP and CAR etc. for the product execution which justify all product quality / material or process attributes with best documentation practices.
- Lead with technical expertise to Finance & Procurement in evaluating vendors for APIs, RMs and equipment and implementing these changes.
- Technical due diligence of potential branded generic products at CROs or EM sites as well as API / Excipient sources.
- Support cost reduction programs and alternate vendors for existing products (CRVIP) in cost effective manner.
- Lead all manufacturing trouble shooting, deviations and investigations and their documentation with closure of CAPA in timely manner.
- Maintain high level planning and alignment with adequate inter- Intra functional communication.
- Ensures effective planning skills to utilize available resources anticipating future technical challenges having current basic regulatory / compliance knowledge.
- Responsible for ensuring team compliance to EHS. Quality and Business policies.
Functional competencies (Skills, Knowledge and Attributes):
Experience in formulation, process development & technology transfer of dosage forms like tablets, capsules, liquids, semi-solids etc.
Expert in global guidance related to research and development, process development and quality risk management with application of DoE/ QbD concepts in development.
Operational knowledge of equipment.
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Candidate Profile
Experience, Education & Certifications:
Minimum 10 years of experience in Formulation Development
Completed Graduation in Pharmacy. Post Graduate will be preferred
Behavioral Competencies:
Detail oriented and highly organized
Able to work well in a team-based environment
Good written & verbal communication skills -Ability to communicate and collaborate across external sites for training, tech transfer and scientific investigations.
Collaborative and trust building nature
Additional Information:
Experience: 10 years
Qualification: B.Pharm, M. Pharm
Location: Greater Mumbai, India
Industry Type: Pharma
Functional Area: F&D
Last date : 15th March, 2017
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