INCOG BioPharma Services Careers

Description

INCOG BioPharma Services is seeking an experienced and detail-oriented Technical Writer to join our Supply Chain Team. This role is critical in supporting our supply chain operations through the creation, maintenance, and optimization of technical documentation that ensures GMP compliance, operational excellence, and seamless communication across global pharmaceutical partnerships. The Technical Writer will work closely with the Supply Chain and other cross-functional teams to create comprehensive documentation that supports development and maintenance of Standard Operating Procedures (SOP’s), Work Instructions (WI’s), Material Specifications, Deviations, Investigations, Change Controls and other compliance documentation ensuring that all documentation meets regulatory and quality standards.

Essential Job Functions:

·       Develop, author, and maintain a wide variety of technical documents, including but not limited to Process Flow Diagrams, Standard Operating Procedures (SOP’s), Work Instructions (WI’s), Material Specifications, Deviations, Investigations, Change Controls ensuring that the information is clear, detailed, and usable by both technical and non-technical stakeholders.

·       Develop and update supplier onboarding documentation, material service agreements/amendments, and other vendor related documentation.

·       Maintain change control documentation for supply chain processes and vendor modifications.

·       Create user manuals, training guides, and other support materials to aid in the onboarding and ongoing education of staff regarding GMP manufacturing processes and protocols.

·       Draft and review deviation reports, CAPA documentation, and investigation summaries related to supply chain issues.

·       Support regulatory submissions by preparing supply chain sections of CMC documentation.

·       Ensure all documentation meets GMP requirements and supports regulatory inspections.

·       Collaborate with Quality teams on batch record documentation and exception reporting.

·       Support business development activities through preparation of technical capability documents.

Special Job Requirements:

·       Associate’s degree in an English major, Supply Chain or in scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Biochemistry, Biotechnology, Engineering). A bachelor’s degree is preferred.

·       Minimum of 1 - 3 years of experience in technical writing within a GMP environment, preferably in the pharmaceutical, biopharmaceutical, or biotechnology industries with supply chain familiarity.

·       Support business development activities through preparation of technical capability documents

·       Collaborate with regulatory affairs on supply chain-related submissions and responses

Additional Preferences:

·       Proficient in writing clear, concise, and accurate technical documentation.

·       Strong understanding of GMP manufacturing processes and regulatory requirements. (includes familiarity with ICH guidelines, FDA regulations (21 CFR Part 211), and ISO standards.

·       Excellent organizational skills with high attention to detail.

·       Ability to collaborate effectively with cross-functional teams and communicate complex information to diverse audiences.

·       Familiarity with documentation tools, electronic document management systems (EDMS) and electronic quality management systems (EQMS).

·       Ability to manage multiple projects and deadlines simultaneously.

·       Advanced knowledge of Microsoft Office Suite, particularly Word, Excel, and PowerPoint.

·       Understanding of pharmaceutical supply chain processes including procurement, inventory management, and vendor qualification

Additional info about INCOG BioPharma Services:

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.