Position

Qualification

Experience

About 10+ years of industrial experience in development of analytical methods for solid and liquid dosage forms

Location

Role

Formulation Development Center (FDC) is an integral part of Syngene offering formulation and analytical development services for new chemical entities (NCEs), generic molecules and OTC products. The incumbent will be leading analytical R&D team responsible for developing and validating analytical methods for variety of dosage forms, managing method transfer, stability studies , providing scientific and technical oversight and interfacing with clients to ensure seamless collaboration with emphasis on high quality and speed.

Skill Set

The knowledge of cGMP principles, and US and EU regulatory guidelines is required. The candidate must possess excellent communication and leadership skills and should be an excellent team player.

Position

Qualification

PhD in Pharmaceutical Sciences

Experience

Location

Role

Formulation Development Center (FDC) is an integral part of Syngene offering formulation and analytical development services for new chemical entities (NCEs), generic molecules and OTC products. The incumbent will be leading formulation R&D team responsible for designing, developing, and delivering a variety of dosage forms as per clients’ requirements, providing scientific and technical oversight and interfacing with clients to ensure seamless collaboration.

Skill Set

The knowledge of technology transfer, scale-up, cGMP, QbD principles, and US/ EU regulatory guidelines is required. The candidate must possess excellent communication and leadership skills. In addition, he/she must also have the vision and a blend of business savvy and technical expertise in order to be effective in interfacing with our global clientele.

Ph.D. with 8-10 years of relevant experience or M Pharm / MVSc with more than 12 years of relevant industrial experience

• The major responsibility will be to lead the Metabolism and Pharmacokinetics group, focused on nonclinical evaluation of new chemical entities, in support of various drug discovery programs ranging from early to late-stage discovery.
• He/she will represent the department at all discovery working group meetings, suggest and implement strategies and tactics to address PK/PD /ADME­ related issues and ultimately enable program decision-making in the selection and advancement of high-quality drug candidates from discovery into development. 
• He/she will collaborate with a broad group of scientists across various disciplines in the Discovery organization.
• The individual will require to play a major role in setting group strategy, vision, and take a lead in key scientific initiatives.

• Hands-on experience and in-depth training in the areas of nonclinical pharmacokinetics (PK), pharmacodynamics (PD) and/or drug metabolism is required. These include, but are not limited to, PK and PK/PD study design and data analysis and interpretation and drug metabolism concepts.
• The scientist should have the understanding and  impact of diseases on DMPK especially in areas of oncology and metabolic disorders.
• Hands-on experience in conducting in vitro and in vivo studies to assess the ADME of discovery compounds (cell culture, metabolic stability models, CYP inhibition etc.) required. Demonstrated experience supporting lead optimization programs, and preclinical candidate characterization to enable studies towards regulatory submissions like IND is necessary.
• Strong problem solving and leadership skills.
• Excellent interpersonal and communication skills (written and verbal) are mandatory in order to perform in a matrix­ team environment.
• Candidate should have strong commitment to team work as well as high levels of integrity, professionalism and personal ethics.

Head - Biologics Pilot Plant

10-12 years of experience in a cGMP facility employing mammalian and/or microbial systems at a pilot/commercial scale with minimum 2 years in a senior managerial role in a manufacturing set up is essential.

• Heading the Biologics plant, the individual will be overall responsible for the operations of a pilot cGMP Biologics/Biopharmaceutical manufacturing facility, in a service-oriented, contract manufacturing mode.  
• He/she need to possess innovative leadership skills for all manufacturing operations in a cGMP-compliant and cost-effective manner.
• The individual will be responsible for resource planning and management.
• The candidate will have to  co-ordinate with QA/QC and drive all quality initiatives. Ensure compliance with quality guidelines / procedures (cGMP)
• Responsible for budgetary planning and monitoring.
• To assess and improvise the process for better / cost effective output.

• Strong Project Management skills with expertise influencing key decision makers within a matrix environment.
• Experience in cGMP Phase I/II manufacturing of biologic, protein therapeutic, recombinant protein or monoclonal antibody drug products, preferably in a contract manufacturing environment.
• Expert knowledge of cGMP standards and proven track record in leading cGMP compliant operations and successful regulatory/client inspections.
• Thorough understanding of biopharmaceutical processdevelopment and manufacturing processes, quality, facilities and regulatory requirements, as well as the application of disposable/modular technologies.
• Demonstrated skills in leadership, communications (oral and written) and teamwork is essential  Ability to identify/recruit talent to expand/augment the existing team is also necessary.