Head - Analytical Development - Pharma/Biotech

JD :

Job Title : Head - Analytical Development

Level: Dy. General Manager

Department : Analytical Development

Location: Bangalore

Reporting To : COO

Positions reporting to this role: Team Leads / Group Leads in the department

Educational Qualification :

- M.Sc/ PhD in Chemistry, Biochemistry, Pharmaceutical Chemistry or any related field.

- Preference is given to candidates with PhD qualification from US or other International reputed universities.

Work Experience :

- Ideal: 15 -18 years. Minimum: 9 years in a leadership role

- Relevant experience in a Pharma / Biotech heading analytical functions.

As the Head of Analytical the key responsibilities would be:

- Responsible for an Analytical team involved in Method development, Method Transfer and Validation for various stages of drug development.

- Method Validation of analytical methods as per internal and country specific regulatory guidelines and execution through proper protocols.

- Responsible for reviewing and approving analytical data in the CMC section of regulatory files.

- Effective method development ensures that laboratory resources are optimized, while methods meet the objectives required at each stage of drug development.

- Responsible for ensuring delivery time-lines and adherence to customer quality and standards and customer Relationship management.

- Facilitating scientific and technical discussions with team members and external collaborators to resolve issues and communicating conclusions from stability studies.

- Participating with group members to explore innovative and improved ways for meeting the group's deliverables while contributing to the scientific depth of the group.

- Demonstrated experience in designing and writing stability protocols for small- or large-molecules, investigational or registration studies, analyzing and trending large sets of data.

Other Responsibilities :

- Build a highly talented team to drive successful integration of objectives. Coach and develop staff; engage in the recruitment, training and retaining talented scientific pool and provide cross-training wherever required.

- Mentor and coach the existing team and developing a pipeline of high caliber and talented professionals with right skill sets. Drive career advancement plans, objective / goal setting, deciding on the Goals & Objectives for direct reports and ensuring a similar approach for down the line reporting in the organization.

- Structure /improve processes and systems to ensure operational excellence in the organization. Direct and guide the team to engage in proposal writing, contract negotiation, sales presentations, and support of client relations.

- As a part of senior leadership team, participate in formulating and reshaping strategies that affect Syngene's growth, operations and future plans.

- Influence the external environment through thought leadership; as well as build visible and active engagement with key opinion leaders, professional societies, academic institutions and most importantly current and future clients to align research to areas of mutual interest.

- Develop productivity metrics and initiatives to improve productivity year on year through combination of talent, processes and technology.