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.
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