Title:  Formulation Scientist

#

Skills

Capabilities

Responsibility

Expectation

1

Core Competency

Responsible for product development for parenteral drug products, which includes pre-formulation, formulation design, process optimization & characterization, and technology transfer from R&D to different manufacturing sites

1. Must have appreciable experience in parenteral drug products formulation and process development, from early to late phase including commercialization
2.  Expertise on selection and process/packaging development of vials, PFS, autoinjectors and its associated regulatory requirements for USA and Europe
3. Extensive experience in de-formulation of reference product, comparability study and it’s characterization
4. Hands on experience for product and process development for both complex and conventional injectable Familiar with analytical characterization techniques for determining purity, potency and similarity assessment for biosimilars

2

Leading

Lead all activities for transferring lab process to GMP manufacturing site and facilitate drug product manufacturing in GMP fill finish facility, in coordination with production and quality team

1. Proven track record for successful completion of technology transfer of complex injectable formulation by using parametric and non-parametric scale-up methodologies
2. Capable to effectively transfer the knowledge to team, through strong reporting and verbal communication
3. Good understanding of engineering principles & process controls related to equipment and processes across scales to transfer or receive processes/ injectable products
4. Hands on experience on process validation and trouble shooting
5. Hands on experience for working in GMP environment, ensuring data integrity and compliance to safety
6. Deep understanding of filter selection, filter optimization and filter validation studies
7. Understanding of containment/isolator requirement for potent large molecules will be plus
8. Preparation and review of drug device combination documents will be additional advantage
9. Know how knowledge for manufacturing process techniques for complex injectables such as liposome, nanoemulsions, polymer conjugates, nanoparticles, microspheres, and complex formation
10. Expertise in design and optimization of lyophilization cycle for large molecules
11. Handful skills for interpretation of results, drawing scientifically based conclusions, writing, and reviewing technical report

3

External Coordination

Experience of working with third party manufacturing facility

1. Work closely with Manufacturing, quality, engineering, and validation teams of third-party manufacturing facility to achieve successful site technology transfer

5

Quality approach

Responsible for optimization of manufacturing processes (right first time approach) to support drug product supply for clinical trials

1. Knowledge of phase appropriate GMP quality system (early phase & late phase) and appreciable understanding of clinical study DP supply requirement

6

Troubleshooting

Drive troubleshooting for technical batches, clinical batches, and registration batches for injectable fill finish facility

1. Expertise in resolving scale-up challenges for drug products ranging from conventional injectables, complex injectables, pre-filled syringes and combination products

7

Compliance

Responsible for writing & review of lab development and GMP manufacturing related proposals & report for client

1. Well versed with the methodology for writing proposal, which shall include detailed scope of project, concise key deliverables, and breakup for project costing components

8

Responsible for managing GMP batch manufacturing documents

1. Expertise in preparation and review of GMP documents such as BMR, BPR, PPQP and PPQR

9

Support for closure of QMS activities such as deviations, OOT, OOS & CAPA closure

1. Well versed with QMS system, scientific methodology for handling product related deviations, OOT, OOS and CAPA, with full awareness of company’s policy and procedures
2. Have a strong power of analysis, illustrated by the ability to quickly recognize the core issues, trends and risks assessment

10

Support for client visit and audits

1. Earlier exposure to regulatory and client audit will be added advantage

1. Capable to handle multiple client audits with due diligence to system improvement

11

Communication and interpersonal skills

Responsible for cross-functional co-ordination

1. Strong management skills with wide experience of working/coordinating both internal & external partners
2. Good oral communication and interpersonal skills for successfully driving programs involving multiple stakeholders

12

Technical superiority

Support for preparation of regulatory query response

1. Prior experience of contributing to regulatory filing of drug product dossier for regulated markets such as US, EU & ROW
2. Expertise in drafting response to regulatory query

13

Agility

Appreciable experience in handling multiple projects within defined timeframe

 1.  Work closely with both functional and project managers to identify and

      mitigate technical issues, manage project milestones to adhere to

       project timelines

14

Support for client visit and audits

1. Earlier exposure to regulatory and client audit will be added advantage
2. Capable to handle multiple client audits with due diligence to system improvement