Head - Analytical Development (pharma Industry) (Karnataka)

Job Description

As the Head of Analytical the key responsibilities would be:

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

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

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

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

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

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

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

8. 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:

1. 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.

2. Mentor and coach the existing team and developing a pipeline of high caliber and talented professionals with right skillsets. 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.

3. 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.

4. As a part of senior leadership team, participate in formulating and reshaping strategies that affect Syngenes growth, operations and future plans.

5. 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.

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

Requirements

WORK EXPERIENCE:

Ideal: 15 -18 years. Minimum: 9years in a leadership role
Relevant experience in a Pharma / Biotech heading analytical functions.

EDUCATIONAL QUALIFICATION:
M.Sc/ PhD in Chemistry, Biochemistry, Pharmaceutical Chemistry or any related field.
Preference is given to candidates with P.hd qualification from US or other International reputed universities.

Company Description

Spectrum Talent Management is a forerunner in designing Human Resources solutions specific… to the local needs of our respected clients. Providing services to clients globally our unique implementation methodology has been developed for speedy ramp-up to cater to the ever urgent needs of the industry as well as ensuring that we apply systems, measures and best practice processes in order to meet the demanding SLAs set by our clients.  Read full description