Principal Analytical Specialist

Syngene International Limited•Baltimore, MD

7d•Onsite

About The Position

Syngene International Ltd. is a global discovery, development, and manufacturing organization providing integrated scientific services to various industries. With a strong focus on innovation and safety, Syngene employs a large team of scientists dedicated to solving scientific problems for its clients worldwide. The company culture emphasizes safety as a core value, with shared responsibility and accountability for following safety guidelines and procedures. The Principal Specialist – Quality Control Analytical (QC Analytical) Lead will be responsible for the Microbiology side of the QC unit at a large molecule manufacturing plant. This role is crucial for ensuring that QC Analytical functions meet regulatory requirements, company goals, and industry best practices. The individual will lead the QC Analytical team, reporting to the Head of Quality Control or Head of Quality in Baltimore. Key responsibilities include developing the site's QC Analytical strategy, interacting with client counterparts, and collaborating with Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain to ensure timely analysis and inspection readiness. This is a hands-on role that involves both leading the QC Analytical group and performing direct QC work, including sampling and testing.

Requirements

Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline is required.
8-12 years of progressively responsible experience in Quality Control within biologics or pharmaceutical manufacturing environments, specifically for large molecule products.
Understanding of USDA and USFDA, ICH, EU, and Health Canada regulations, as well as USP and other pharmacopeial standards relevant to biologics manufacturing.
Proven experience supporting regulatory inspections and third-party audits.
Strong working knowledge of biologic analytical techniques and validation of methods.
Demonstrated ability to lead cross-functional teams, build relationships across departments, and foster a culture of quality, compliance, and accountability.
Skilled in implementing robust quality systems, qualifications and validations and product lifecycle quality management.
A track record of driving successful continuous improvement projects to enhance efficiency, reduce deviations, and increase product quality.

Nice To Haves

Master’s degree is desired.
Experience in bioanalytical and bioassay methods for monoclonal antibodies and other biologic molecules.
Plan and manage resources for smooth operations in the QC analytical lab.

Responsibilities

Responsible for Quality Control (QC) Analytical operations, including product support for stability studies, raw material, microbiology lab and packing material testing, ensuring compliance with Good Laboratory Practices (GLP) and applicable regulatory requirements.
Manage routine analytical tests on raw materials, on intermediate and finished products, and for facility utilities, such as water, gas, and environmental sampling.
Operate as the lead specialist in performing routine sampling and testing for all analytical tests, including for utility, raw material, in-process and product, and stability.
Coordinate with Quality Assurance (QA), and other departments to ensure development and transfer of analytical tests and methods.
Ensure qualification, validation, performance, and transfer of analytical methods within the QC department.
Interact with clients and project teams to ensure seamless execution of project-related activities.
Ensure all QC test methods, protocols, and technical reports related to Analytical operations comply with current pharmacopeial and regulatory requirements.
Collaborate with the Biologics Process Development team to plan and execute testing activities in support of drug substance development and manufacturing.
Ensure that laboratory incidents, out-of-specifications (OOS), deviations, out-of-trend (OOT) results, and client complaints related to QC testing are thoroughly investigated, root causes identified, and corrective and preventive actions (CAPA) implemented in a timely manner.
Ensure all documentation, including SOPs, IOPs, EOPs, and STPs, is periodically reviewed, updated, and maintained as per the documentation control system.
Ensure timely completion of QC activities as per project timelines. Update work plans periodically to accommodate changes in project scope, priorities, or timelines.
Adhere to ALCOA principles of data integrity for self and ensure compliance by team members.
Establish functional working teams for self-assessment of compliance to SOPs and data integrity standards.
Ensure preparation and timely closure of audit action plans and escalate concerns appropriately.
Lead investigations and ensure closure of client and regulatory audit observations related to QC Analytical.
Ensure lab safety protocols are followed at all times and resolve technical issues in the QC Analytical lab effectively.
Support QC Analytical documentation in regulatory filings, including Prior Approval Submissions, renewals, updates, and supplements, as required.
Manage, coach, and develop the QC Analytical team and contribute to their professional growth.
Proactively monitor QC analytical trends, complaints, failures, deviations, and changes to identify opportunities for process, system, and product improvements.