Title:  Formulation Scientist

JOB DESCRIPTION

Job Title: Formulation Scientist

Job Location: S18, Syngene, Bengaluru

Department: Formulation Development Centre (FDC)

About Syngene:  Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific  services from early discovery to commercial supply.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit

Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned.
• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards.
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
• Compliance to Syngene’ s quality standards at all times
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time

Core Purpose of the Role :

• 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.
• To 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.
• To responsible for optimization of manufacturing processes (right first time approach) to support drug product supply for clinical trials

Role Accountabilities

• Hold self-accountable for the achievement of client milestone.
• Meet Compliance related expectation

Leadership Capabilities

• Self-Driven
• Self-Motivated
• Communication and coordination to deal with cross functional teams

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Accountabilities as a Syngene Leader (only for Leadership Hires)

• Champion effective Environment, Occupational Health, Safety and Sustainability (EHSS) practices for the company and oversee compliance with those practices within Biologics business. Play an active leadership role in monitoring and verifying safety performance through Gemba walks and other safety-led activities.
• Foster a corporate culture that promotes an environment, occupational health, safety, and sustainability (EHSS) mindset as well as the highest standards of quality, integrity, and compliance.

• Put people at the heart of our success by providing clear, active leadership defined by the Syngene leadership framework setting high standards of people management, career planning and talent retention as a priority.

Experience:

At least 5 years of industrial research experience in formulation development and technology transfer of parenteral drug products for small molecules & large molecules

Skills and Capabilities:

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

Expectation

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

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

External Coordination

Experience of working with third party manufacturing facility

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

Quality approach

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

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

Troubleshooting

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

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

Compliance

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

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

Responsible for managing GMP batch manufacturing documents

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

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

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

Have a strong power of analysis, illustrated by the ability to quickly recognize the core issues, trends and risks assessment

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

Communication and interpersonal skills

Responsible for cross-functional co-ordination

Strong management skills with wide experience of working/coordinating both internal & external partners

Good oral communication and interpersonal skills for successfully driving programs involving multiple stakeholders

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

Agility

Appreciable experience in handling multiple projects within defined timeframe

Work closely with both functional and project managers to identify and mitigate technical issues, manage project milestones to adhere to project timelines

Support for client visit and audits

Earlier exposure to regulatory and client audit will be added advantage

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

Education:

Master of Pharmacy (Pharmaceutics or industrial pharmacy or process technology)

Equal Opportunity Employer

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.