Invites for Associate Scientific Manager-F&D– Parenteral Dosage form in Biocon

Biocon is a research-driven, global healthcare company with a strong matrix of capabilities along the biopharmaceutical value chain. Focusing on unmet medical needs in cancer, diabetes and inflammatory diseases, it offers novel therapies on a platform of affordable innovation.
Biocon together with group companies employs more than 2500 employees with approxmimately Rs 1,000 crore turnover and is expected to grow further during the current financial year.

Post: Associate Scientific Manager-Formulation Development– Parenteral Dosage form

Job description

Core formulation development expertise with at least 7 years of experience in developing Injectable products for regulated markets for small molecules & peptides for 505(j) & 505B(2) filings.
Good understanding of QbD requirements for development formulation which shall include (but not limited to) QTPP, CQA, CMA, CPP, CS, DOE, FMEA, etc
Hands on experience of developing a Lyophilized dosage forms with intensive knowledge of Freeze drying process.
Sound understanding on leachable extractable, filter validations, methods of sterilization, etc which is essential for development of injectable dosage forms.
Set-up of formulation R&D, creating tailor made SOPs, laying down standard development processes through guidance’s for effective functioning of the department.
DOE based process optimization & successful technology transfer at the manufacturing site for demonstration of registration batch manufacturing.
Review & ensure completeness of QbR based dossier for filing with help of regulatory teams along with other technical documents writing.
Work closely with formulation managers (other dosage forms) & extend help in delivery of projects on time.
Complete understanding of USFDA, EMA, MHRA, and ICH guidelines, and the regulatory requirements of various International Regulatory Agencies
Specification setting, Polymorphism, Interpretation of Characterization data, ICH Stability Studies, compliance to 21 CFR Part 11, review support to regulatory submissions, and support to Intellectual Property Group etc
End to end responsibility to support the multiple formulation projects for regulated markets by day-to-day experimental planning & execution.

Project-wise documentation of all the development activities, creating formats for data updating and release to stakeholders for regular analysis as well as stability studies.

Desired Skills and Experience
Behavioural skills
Key strength shall be to work as formulation lead with an ability to communicate and influence to achieve delivery of objectives often to tight deadlines.
Familiar of both technical and professional management of external teams and technical coaching of internal colleagues to deliver projects with in deadlines.

A team member with leadership skills who maintain rapport & relationship with internal as well as external stake-holders.
Business acumen, Interpersonal Skills, and Result Orientation is something person must have.
Thrive to achieve overall business goals for the organization with passion & self-motivation.

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Qualification
M Pharm/M Tech/MS/PhD in Pharmaceutical sciences, Pharmaceutics, industrial pharmacy or allied sciences.

Experience
6 to 9 Years of experience in the formulation research; especially in the regulated markets out of which at least 3 to 5 Years shall be in managerial position.
Experience in setting up a formulation development lab will be an added advantage.

Additional Information:
Experience: 3-5 Years
Location: Bengalore
Education: M Pharm/M Tech/MS/PhD
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: F&D
End Date: 26^th Sep., 2013