HOD – Formulation & Process

PERFECT PLACER
  • Delhi
  • Confidential
  • 7-15 years
  • Views
  • 05 Oct 2018

  • Production/ Manufacturing/ Engineering

  • FMCG/ Foods/ Beverages
Job Description

Perfect Placer along with its associate services has a long and prestigious list of leading Indian and Multinational Corporates in India and Outside across Managerial levels, functions and Industries, covering both IT and Non-IT specialized in chief executive, board member and senior-level management search assignments
HOD – Formulation & Process (Skin Care)
The Head of Formulation and Process Development is expected to lead, design and oversee scientific studies in support of technical programs as they progress from early development into confirmatory development, technology transfer up to the registration and to support as needed manufacturing process at the commercial site.

(1)- Operations:
o Design and lead specific formulation and manufacturing process development plan in cooperation external partner, in line with business priorities, following the Quality by Design framework
o Responsible for the conception, design, and interpretation of scientific and technical data to support projects decision making
o Collaborate with scientific staff to design, implement, and interpret the data from development projects
o Solve complex problems through collaborations with others, taking a new perspective on existing solutions
Generate strong relationships in the area of small molecule development with preferred partners beneficial to the organization, both internally and externally, to deliver innovative products, pre-clinical and clinical materials
o Identify, technically qualify and recommend external partner (e.g. CDMO, Academia) and set strategic partnership (e.g. raw material suppliers, packaging suppliers)
o Prepare and present data to internal project team meetings
o Function effectively as a core team member on multiple concurrent project developments
o Ensure close liaison with Operations to prepare, execute and support technical transfer to the late stage of development
o Communicate effectively within Development Department and beyond and with external partners (e.g. Suppliers, Vendors) and is able to defend scientific and technical decisions at the appropriate governance body / meeting
o Contribute to set a risk management table, update it as necessary and escalade in a timely manner any critical risk
o Contribute to define and execute mitigation and contingency plan
o Plan efficiently activities and ensure strict monitoring of milestones and budget
o Act as a voice and ambassador of its department at various governance bodies / meetings

(2)- Regulatory Submissions, Documentation and Compliance:
o Author, review and/or approve key documents such as: formulation development reports, manufacturing process development report, technology transfer document, justification of in process controls, and relevant sections of regulatory filings (IND, IMPD, CTD)
o Author standard operating procedures and working instructions required by the activities
o Ensure close oversight of GMP activities that are conducted externally to ensure at each stage of development an appropriate level of quality requirements
o Ensure that external partners operate in compliance with Safety, Health and Environment Co’s policy
Actively contribute to the preparation of audits and inspections, internally or at external partner’ site

(3)- Knowledge Management:
o Scoot and benchmark specific technologies in the field of small molecule formulation and process development and ensure knowledge acquisition
o Monitor, assess and proactively contribute to implement regional regulatory requirements and guidelines that impact formulation and process development activities in close cooperation with Department
o Ensure communication and training within the Organization
o Identify and attend congresses and forum to ensure continuous expertise growth and visibility of Skin Health
Publish/present in high quality journals/conferences

(4)- Other activities:
o Contribute to the innovation and continuous improvement process by proposing solutions in line with the strategy of the Co’s.
o Contribute on purpose to due diligence, scientific assessment of external opportunities and divesting projects
o Define and execute strategy for patent submission and/or defense in close cooperation with Industrial Property Team
o Proactively support biologic downstream process development
o Contribute to Department budget preparation and ensure continuous monitoring

Qualification And Experience:
1. BSc in Chemistry or Pharmaceutical Sciences or Pharmacist or closely related to the field
2. At least 10+ years of relevant experience in Skin Care industry
3. Established track record of success with topical developments
4. Experience working with external partners (e.g. CDMO, Academic)
5. Sound technical qualifications and deep knowledge in developing formulation strategy and manufacturing process engineering including primary packaging
6. Demonstrated laboratory experience in the field and in developing innovative solutions
7. Solid understanding of characterization and performance of product, notably when screening formulations
8. Excellent understanding of cGMP, ICH guidance and applicable guidelines
9. In-depth knowledge how to implement a Quality by Design approach including design of experiment and statistical analysis
10. Experience in authoring development and regulatory submissions
11. Excellent communication, negotiation and external follow-up
12. Excellent verbal and written communication skills (English) and the ability to work in a team environment with cross-functional interactions
13. Sufficient knowledge of FDA, BIS & ECOCERT regulations

14. Experience in complying with Quality Control/Quality Assurance expectations

15. Self-motivated and proactive with demonstrated creative and critical thinking capabilities

16. Interact with suppliers to ensure internal quality and regulatory requirements are met

17. Team player with strong interpersonal and executive communication skills
18. Ability to multitask and adapt to a rapidly evolving product environment


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