23 Oct
Syngene International
Kolhapur
JOB DESCRIPTION
Job Title: Group Leader – NCE Early formulation development and CMC development
Job Location: Bangalore
Department: Formulation Development
About Syngene :Syngene ( ) 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 :
We are seeking a highly skilled and motivated individual experience in early-stage formulation development and integrated CMC development for First in human formulations to join our team. As a group leader for Formulation development and integrated CMC, he will be responsible for managing a team and serving as the primary point of contact for our clients. The successful candidate will possess strong leadership abilities, excellent communication skills, and a deep understanding of CMC (Chemistry, Manufacturing, and Controls) processes for first in human development and IND.
Role Accountabilities
- Provide strategic guidance and expertise in CMC development, including process optimization, scale-up, and validation activities.
- Collaborate cross-functionally with R&D;, manufacturing, quality assurance,
and regulatory affairs teams to ensure alignment and seamless execution of CMC strategies.
- Drive continuous improvement initiatives to enhance efficiency and effectiveness in CMC.
- Lead the solid-state characterization efforts to assess the physical and chemical properties of drug substances and formulations, including polymorphism, crystallinity, and particle size distribution.
- Utilize techniques such as X-ray diffraction (XRD), differential scanning calorimetry (DSC), and microscopy to characterize solid-state forms and ensure product stability and performance.
- Direct the formulation development activities for preclinical studies, focusing on optimizing drug delivery systems to enhance stability, solubility, and bioavailability.
- Collaborate with preclinical research teams to design and develop formulations suitable for in vivo studies, ensuring compatibility with animal models and study objectives.
- Implement strategies to enhance the bioavailability of drug candidates, including formulation approaches such as solid dispersion, lipid-based formulations, and nanoparticle delivery systems.
- Evaluate and optimize formulation parameters to improve drug dissolution, absorption, and systemic exposure, thereby maximizing therapeutic efficacy.
- Stay abreast of relevant regulatory guidelines and requirements related to CMC activities in the pharmaceutical industry.
- Ensure compliance with regulatory standards and guidelines in all CMC-related activities and documentation.
- processes
Team Management:
- Provide guidance and support to team members to ensure project objectives are met on time and within budget.
- Ensure implementation of best practices for human relation management through proper recruitment, training practices & retention of good performing employees of department
- Responsible for enhancing productivity and team building.
- Ensure that individual team member adheres and follows the systems and SOP and provide training for the same.
- Oversee the planning, execution, and completion of integrated CMC projects, ensuring adherence to quality standards and regulatory requirements.
- Develop project plans, timelines, and budgets, and monitor progress to ensure milestones are achieved.
- Identify and mitigate risks and escalate issues as necessary to ensure successful project delivery.
- Foster a collaborative and high-performance work environment.
Qualifications:
Minimum of 15 years of experience in NCE early stage development and CMC development within the pharmaceutical or biotechnology industry.
Strong leadership and team management skills, with a demonstrated ability to lead and develop high-performing teams.
Excellent communication and interpersonal skills, with the ability to effectively interact with clients, internal stakeholders, and cross-functional teams.
Proven track record of successfully managing integrated CMC projects from concept to commercialization.
Deep understanding of CMC processes, including formulation development, process optimization, analytical characterization,
and regulatory requirements.
Experience with regulatory submissions (e.g., IND, NDA) and interactions with regulatory agencies (e.g., FDA, EMA) is preferred.
Strong problem-solving skills and ability to work effectively in a fast-paced and dynamic environment.
Leadership Capabilities
Syngene Values
All employees will consistently demonstrate alignment with our core values
Excellence
Integrity
Professionalism
Accountabilities as a Syngene Leader
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: Minimum of 15 years of experience in NCE early stage development and CMC development within the pharmaceutical or biotechnology industry
Education: PhD
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.
▶️ Group Leader - NCE- Formulation Development
🖊️ Syngene International
📍 Kolhapur