Sr. Executive – Analytical Development (AD)
Job Title: Sr. Executive – Analytical Development (AD)
Location: Ambernath, India
Job Type: Full Time
Reporting: Head of Research & Development
About Polypeptide Group:
PolyPeptide Group AG and its consolidated subsidiaries (“PolyPeptide”) is a specialized Contract Development & Manufacturing Organization (CDMO) for peptide- and oligonucleotide-based active pharmaceutical ingredients. By supporting its customers mainly in pharma and biotech, it contributes to the health of millions of patients across the world. PolyPeptide serves a fast-growing market, offering products and services from pre-clinical to commercial stages. Its broad portfolio reflects the opportunities in drug therapies across areas and with a large exposure to metabolic diseases, including GLP-1. Dating back to 1952, PolyPeptide today runs a global network of six GMP-certified facilities in Europe, the U.S. and India. PolyPeptide’s shares (SIX: PPGN) are listed on SIX Swiss Exchange.
Position Overview:
We are looking for a passionate and experienced Sr. Executive – Analytical Development to join our dynamic R&D team. This role is ideal for professionals with a strong foundation in analytical chemistry and a drive to innovate in the peptide and protein space. You will play a key role in developing and validating analytical methods that support cutting-edge pharmaceutical research.
Key Responsibilities:
- Design and develop robust analytical methods for active pharmaceutical ingredients (APIs), in-process materials, and raw materials.
- Optimize and troubleshoot existing methods to enhance accuracy, efficiency, and reliability.
- Lead investigations into method performance issues and analytical discrepancies.
- Conduct method validation and verification in alignment with regulatory standards and internal quality systems.
- Provide comprehensive analytical support for R&D samples, including stability studies.
- Prepare and maintain detailed documentation such as validation protocols, verification reports, and technical summaries.
- Author and update Standard Operating Procedures (SOPs) to ensure consistency and compliance.
- Coordinate with external vendors for instrument calibration and ensure timely execution.
- Oversee IQ, OQ, PQ, and qualification activities for analytical instruments.
- Manage and document stability testing, ensuring accurate tracking and reporting.
- Maintain Annual Maintenance Contract (AMC) records and instrument history logs.
- Troubleshoot analytical instruments and ensure uninterrupted lab operations.
- Uphold Good Laboratory Practices (GLP) and ensure all work complies with approved procedures and quality standards.
Must-Have Qualifications:
- M.Sc. in Analytical/Organic Chemistry or equivalent.
- Minimum 5 years of relevant experience in analytical development.
- Strong background in method development, validation, and troubleshooting.
- Experience in peptide/protein/pharma industries is highly desirable.
- Familiarity with regulatory guidelines and documentation practices.
Preferred Qualifications (Add-ons):
- Hands-on experience with HPLC, GC, UV, IR, and LC-MS instrumentation.
- Familiarity with ICH guidelines and regulatory expectations for method validation and stability studies.
- Exposure to peptide and protein characterization techniques.
- Experience working in regulated environments such as GMP/GLP labs.
- Proficiency in analytical documentation systems and LIMS.
- Ability to manage instrument qualification (IQ/OQ/PQ) and calibration workflows.
- Strong troubleshooting skills for analytical instrumentation and method-related issues.
- Knowledge of stability study protocols and data interpretation.
- Effective communication and collaboration skills for cross-functional R&D support.
Why Join Us at Polypeptide Group:
Polypeptide Group offers an exciting opportunity to work at the forefront of peptide-based therapeutics, a rapidly growing and innovative segment of the pharmaceutical industry. As a key member of PolyPeptide team, you will have the opportunity to contribute to a company that is dedicated to the success of its clients and the advancement of peptide science. Join us and be part of a global organization that is shaping the future of life-saving therapies.
- Department
- Research & Development
- Locations
- Ambernath
Ambernath
Our Core Values
INNOVATION
- We are curious and explore new ways.
- We are also ambitious and find solutions.
EXCELLENCE
- We have a strong technical knowledge, and we deliver results
- We lead quality in everything we do
- We are adaptable and customer focused
TRUST
- We believe in teamwork and collaboration.
- We lead by example and accept responsibility
- We are transparent and we show integrity.
About PolyPeptide Group
PolyPeptide Group AG and its consolidated subsidiaries (“PolyPeptide”) is a focused Contract Development & Manufacturing Organization (CDMO) for peptide- and oligonucleotide-based active pharmaceutical ingredients. By supporting its customers mainly in pharma and biotech, it contributes to the health of millions of patients across the world.
PolyPeptide offers products and services from pre-clinical through to commercial stages, including generics. Its active custom projects pipeline reflects the opportunities from novel drug therapies in development to fight both widespread and rare diseases. Dating back to 1952, PolyPeptide today runs a global network of six cGMP-certified facilities in Europe, the U.S. and India. PolyPeptide Group AG’s shares (SIX: PPGN) are listed on SIX Swiss Exchange.