Quality Control Chemist Summary: INCOG is seeking a Quality Control (QC) Chemist with a passion for working within a team, a desire to drive Quality processes in a regulated setting, and a commitment to upholding the int…
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Reliability Engineering Technician - Lilly Medicine Foundry
Indianapolis, Indiana, United States · On-site
$33/hr–$49/hr
Mid level$6.5B raised
At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headqua…
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$70k–$85k
Full-time
bachelor degree
Posted 41d ago
~40 hrs/week
Responsibilities
Perform routine and batch-related testing on raw materials, in-process samples, and finished products within a GMP environment. Support the analytical method life cycle through the creation of SOPs, laboratory investigations, and equipment maintenance.
Requirements
Requires a Bachelor's degree in Chemistry or Biochemistry and at least 3 years of biopharma experience, including 2 years in a GMP setting. Proficiency in various analytical instrumentation and data management systems is essential.
Full job description
Quality Control Chemist Summary:
INCOG is seeking a Quality Control (QC) Chemist with a passion for working within a team, a desire to drive Quality processes in a regulated setting, and a commitment to upholding the integrity of data generated for clients.
The QC Chemist will work closely with the QC Chemistry Manager and Quality Control Method Transfer Scientists, as well as Project Management and Supply Chain teams, to support development, readiness, and routine testing activities for the Quality Control Chemistry laboratory.
This role is crucial in generating ALCOA+ data and upholding our Quality Mindset through attention to detail, on-time delivery, and commitment to Quality excellence. Strict adherence to Good Documentation Practices (GDP) is required as Good Manufacturing Practice (GMP) testing is performed.
Excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences is critical in this role. The QC Chemist will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, clients, suppliers, and partners. The QC Chemist will thrive in a team environment but can also work autonomously with strong self-management and organizational skills.
Essential Job Functions:
Perform routine and batch-related testing on incoming components, raw materials, in-process samples, finished product, and stability samples according to validated methods as well as special testing deemed necessary by protocols
Assist in sampling and testing of incoming materials requiring QC testing as needed
Create/revise SOPs and other relevant documents related to laboratory equipment and/or processes
Participate in the completion of laboratory investigations/deviations and provide SME support where needed
Perform basic troubleshooting activities with respect to methods/assays, equipment malfunctions, and investigations (Deviations and OOS)
Execute routine laboratory work orders for maintenance and non-critical calibrations
Perform minor preventative maintenance on QC laboratory instrumentation as needed using written SOPs or assist vendors with access to systems/materials when vendor performs maintenance
Execute day-to-day tasks within the laboratory including sample inventory disposition/disposal, consumables ordering/inventory, preparing instruments for testing, and laboratory waste management
Assist in the control and management of laboratory waste in cooperation with relevant EH&S standards
Assist in the development and execution of protocols for method transfers, method validations, stability studies, cleaning validations, and any other special testing required from the Quality Control Chemistry laboratory
Support internal and external customers to ensure proper and timely execution of all aspects of the clinical/commercial analytical method life cycle across clients
Conduct periodic reviews of analytical test procedures and SOPs as required
Review and approve analytical testing procedures and protocols as needed
Assist in training fellow QC and Development personnel on instruments and assays when cross-training is needed
Assist in the professional support and development of QC Chemistry Technician staff within the QC laboratory
Be team-oriented and willing to act as both a facilitator of special projects and a contributor to special projects when needed
Set deadlines and prioritize work for self, group members, and support groups involved
Review/approve work performed by coworkers for accuracy and alignment with procedures
Collaborate with internal departments and teams to resolve quality issues regarding facility, products manufactured, and released
Identify, evaluate, and implement continuous business process improvements
Special Job Requirements:
This position will support primarily third shift (11:00pm-7:30am)
Bachelor's Degree in Science (Chemistry or Biochemistry)
Minimum of 3+ years of biopharma industry experience, with at least 2 years of hands-on experience in a GMP environment/Quality Control testing in a regulated environment or other related experience
High proficiency level in operating UHPLC/HPLC, GC, SoloVPE, UV-VIS, TOC, particulate matter analyses, method validation/transfer, and relevant laboratory computer systems with associated data integrity requirements
Excellent working knowledge, understanding, and experience with practical implementation of FDA, EMA, and other regulatory authority expectations for Quality Control
Exceptional computer skills evidenced by hands-on work with automated data management and/or data analysis systems (LIMS, JMP, Minitab, etc.)
Additional Preferences:
Experience with Continuous Improvement, Six Sigma, and/or Lean principles
Experience with building processes and procedures
Experience in performing testing and/or characterization of biologic (monoclonal antibody, enzyme) and small molecule (peptide, mRNA) products
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
By submitting your resume and details, you are declaring that the information is correct and accurate.
Related keywords
QC ChemistBiopharmaGMPGDPALCOA+UHPLCHPLCGas ChromatographySoloVPEUV-VISTOCLIMSJMPMinitabMethod ValidationMethod Transfer
A CDMO with an unparalleled customer-centric approach.
Industry
Biotechnology Research
Company size
501-1,000 employees
Founded
2020
Headquarters
Fishers , Indiana
LinkedIn followers
19,368
Total funding
$87M
Our services support injectable drug products, including technical transfer, analytical method development and validation, process scale up, and formulation & filling of vials, syringes and cartridges. In addition, we offer customized packaging services to include labeling, device assembly, auto injector assembly, cartoning,
final packaging and integrated storage solutions at various temperature conditions.
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