Job Title: Specialist – Quality Control Microbiology Reporting to: Head of Quality Control Microbiology Department: Quality Control Location: Baltimore, Maryland About Syngene Incorporated in 1993, Syngene International …
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Full-time
bachelor degree
Posted 9d ago
Apply by Oct 30
~40 hrs/week
Responsibilities
The Specialist will perform routine microbiology sampling and testing while ensuring compliance with GLP and regulatory standards. They will also coordinate method development, validation, and transfer activities while managing laboratory investigations and CAPA processes.
Requirements
Candidates must hold a bachelor's degree in a scientific discipline and possess 5-8 years of experience in quality control within biologics or pharmaceutical manufacturing. Strong knowledge of regulatory requirements such as USFDA, ICH, and EU standards is required.
Full job description
Job Title: Specialist – Quality Control Microbiology
Reporting to: Head of Quality Control Microbiology
Department: Quality Control
Location: Baltimore, Maryland
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, and Merck KGaA. 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.
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.
Job Summary
The Specialist – Quality Control Microbiology (QC Microbiology), will serve as an analyst/specialist for the Microbiology side of the QC unit at a large molecule manufacturing plant. The incumbent will work within the QC Microbiology group for the site and partner cross-functionally with QC Analytical, Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain to ensure timely analysis and inspection readiness. This role is a working Specialist role, and will include hands-on QC work, including sampling and testing, as well as working with analysts and specialists within QC Microbiology group to develop, qualify/validate, and transfer methods.
Primary Responsibilities
Responsible for working in Quality Control (QC) Microbiology operations, including product support for stability studies, raw material, ensuring compliance with Good Laboratory Practices (GLP) and applicable regulatory requirements.
Operate as the specialist in performing routine sampling and testing for all Microbiology 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 microbiology tests and methods.
Ensure qualification, validation, performance, and transfer of Microbiology methods within the QC department.
Interact with clients and project teams to ensure seamless execution of project-related activities.
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.
Participate in functional working teams for self-assessment of compliance to SOPs and data integrity standards.
Support preparation and timely closure of audit action plans and escalate concerns appropriately.
Support investigations and closure of client and regulatory audit observations related to QC Microbiology.
Ensure lab safety protocols are followed at all times and resolve technical issues in the QC Microbiology lab effectively.
Support QC Microbiology documentation in regulatory filings, including Prior Approval Submissions, renewals, updates, and supplements, as required.
Support monitoring of QC microbiology trends, complaints, failures, deviations, and changes to identify opportunities for process, system, and product improvements.
Education & Qualifications
Education: Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline is required;
Experience: 5-8 years of progressively responsible experience in Quality Control within biologics or pharmaceutical manufacturing environments, specifically for large molecule products.
Regulatory Knowledge: Understanding of USDA and USFDA, ICH, EU, and Health Canada regulations, as well as USP and other pharmacopeial standards relevant to biologics manufacturing.
Audit Experience: Experience supporting regulatory inspections and third-party audits.
Technical Expertise: Working knowledge of biologic techniques and validation of methods.
Leadership Skills: Ability to lead cross-functional teams, build relationships across departments, and foster a culture of quality, compliance, and accountability.
Training & Development: Experience working within quality systems, qualifications and validations and product lifecycle quality management.
Continuous Improvement: A track record of driving successful continuous improvement projects to enhance efficiency, reduce deviations, and increase product quality.
Additional Competencies:
Experience in bioanalytical and bioassay methods for monoclonal antibodies and other biologic molecules.
Plan and manage resources for smooth operations in the QC Microbiology lab.
Equal Opportunity Employer:
It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, colour, 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.
Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022) is an integrated research, development, and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors.
Syngene's more than 6000 scientists offer both skills and the capacity to deliver great science, robust data security, and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation.
With a combination of dedicated research facilities for Amgen, Baxter, and Bristol-Myers Squibb as well as 2 Mn sq. ft of specialist discovery, development and manufacturing facilities, Syngene works with biotech companies pursuing leading-edge science as well as multinationals, including GSK, Zoetis and Merck KGaA.
For more details, visit www.syngeneintl.com or write to us at [email protected]
Offices: Syngene International Ltd, Biocon Park, Bommsandra Industrial Estate, IV Phase, Jigani Link Road, Bommsandra, Bengaluru, Karnataka 560099, IN · Knowledge Square Park -9000, Plot NO.7, Survey No.542, MN Park, Synergy Square 2 Genome Valley, Kolthur Shamirpet, Medchal, Hyderabad, Hyderabad, Telangana 500078, IN · MSEZ, Permude, Mangaluru, Karnataka 574142, Mangaluru, Karnataka 574142, IN
Drug DiscoveryDrug DevelopmentDrug ManufacturingSmall MoleculesBiologicsIntegrated Drug DiscoveryPeptidesOligonucleotidesAntibody Drug ConjugatesPROTACs
How many Science & Research jobs are open in Baltimore, MD right now?
There are currently 886 open science & research positions in Baltimore, MD listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Science & Research roles in Baltimore, MD?
Companies currently hiring include John Hopkins University, University System of Maryland, Northrop Grumman, Northrop Grumman Mission Systems, Inc., University of Maryland Medical System, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Science & Research jobs in Baltimore, MD?
Yes — 227 of the 886 open science & research positions offer remote or hybrid work (55 remote, 172 hybrid).
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