Research Director - Analytical Development Job in Syngene International

Designation: Research Director

Job Location: Bangalore

Department: Analytical Development

About Syngene

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

Job purpose

• Responsible for an Analytical team involved in method development, method transfer and validation for various stages of drug development and stability testing under cGMP conditions.
• Responsible for Method development of stability indicating assay methods, impurity test methods for drug substances and different types of formulations such as tablets, capsules, solutions and creams

Key Responsibilities:

• Responsible for Method development of stability indicating assay methods, impurity test methods for drug substances and different types of formulations such as tablets, capsules, solutions and creams.
• Responsible for analytical testing, in-process, finished product release and ICH stability studies for early phase cGMP batches for drug substance and drug product.
• Responsible for ensuring safety and quality compliance and best practices for Analytical development function, compliance of QMS activities, good laboratory practices, 21 CFR Part 11 compliance and regulatory requirements. Lead and manage regulatory and client audits for Analytical Development function
• Effective method development ensures that laboratory resources are optimized, while methods meet the objectives required at each stage 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.
• Contributing to establishing the stability study strategy for drug substances/drug products for assigned projects and guides teams on this strategy.
• Analyzing the trends and stability data. Identify issues, summarizes and presents results from stability studies and authors technical memos and reports.
• Facilitating scientific and technical discussions with team members and external collaborators to resolve issues and communicating conclusions from analytical development and stability studies.
• Managing the process of authoring the analytical development and stability section in investigational and registration global filings and responds to stability-related questions from health authorities within the established timelines.
• Participating with group members to explore innovative and improved ways for meeting the groups deliverables while contributing to the scientific depth of the group.
• Ensuring a sustainable portfolio of analytical development operations and projects to deliver project objectives maintaining productivity and competitiveness against internal and external benchmarks.
• Responsible for ensuring delivery timelines and adherence to customer quality and standards and customer relationship management.
• Possess the knowledge and exposure to environment, health, and safety (EHS) practices
• Ensure the development of effective environment, health, and safety (EHS) practices for the company and oversee compliance with those practices
• Foster a corporate culture that promotes environment, health, and safety (EHS) mindset at workplace
• Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
• Ensure environment, health, and safety (EHS) measures are imparted via training and adhered within the team

Additional Job 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 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.
• 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, support of client relations.
• As a part of senior leadership team, participate in formulating and reshaping strategies that affect Syngenes 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.
• Strategic planning and financial budget management as per defined plans for individual sections within Analytical Development functions

Educational Qualification:

• Ph.D/Masters degree in Chemistry, Biochemistry, Pharmaceutical Chemistry or any related field.

• Responsible for an Analytical team involved in method development, method transfer and validation for various stages of drug development and stability testing under cGMP conditions.
• Responsible for Method development of stability indicating assay methods, impurity test methods for drug substances and different types of formulations such as tablets, capsules, solutions and creams.
• Effective method development ensures that laboratory resources are optimized, while methods meet the objectives required at each stage 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

Experience:

• 15-19 years post qualification, Candidate must have performed minimum 8 years on leadership role

Behavioral Skills:

• Should have the capability to work in a team and ability to handle demonstrate a good team spirit.
• While possessing a good ability to follow instruction should also demonstrate innovative in his/her approach, good communication skills.
• Should be proactive while working on allotted responsibility.

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.