Supply Chain Specification Writer
INCOG Biopharma Services in Indianapolis, IN is hiring a Supply Chain Specification Writer. They are seeking a highly motivated individual and detail-oriented who will help with supporting development, processing and issuance of specifications for their brand new CDMO facility.
INCOG BioPharma Services is seeking an experienced and detail-oriented Specification Writer to join our Supply Chain Team. This role is crucial for translating complex technical data into clear, accurate, and accessible documentation. The Specification Writer will work closely with Supply Chain, External Vendors, Clients and other cross-functional teams to create comprehensive documentation that supports new material specifications and updates for existing specifications, ensuring that all materials meet regulatory and quality standards.
There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.
At INCOG, they are more than just a CDMO. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At their core, that is who they are—a dedicated team that believes they can always be better.
Join the team at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients for yourself, their clients, and patients.
Job Functions:
- Develop, author, and maintain material specifications, ensuring that the information is clear, detailed, and usable by both technical and non-technical stakeholders.
- Work closely with Supply Chain, vendors, Quality, project teams, and clients to gather necessary technical information, facilitate effective communication, and ensure that all documentation reflects the latest material information and stakeholder feedback.
- Understand material requirements, track progress of specifications, and support prioritization to ensure operational readiness.
- Support escalation, documentation, and generate action items for path forward when specification approval does not align with operational timelines or requirements.
- Establish and maintain documentation standards to ensure consistency across all technical documents. Continuously review and update documents to reflect process improvements, new requirements, and regulatory changes.
- Create user manuals, training guides, and other support materials to aid in the onboarding and ongoing education of staff regarding material specifications.
Candidate Requirements:
- Education: College Degree or Equivalent experience demonstrated in this field
- Experience: 2-4 years previous experience in a Specification / Technical Writer role (pharma preferred)
- Strong understanding of GMP manufacturing processes and regulatory requirements.
- Excellent organizational skills with high attention to detail.
- Ability to collaborate effectively with cross-functional teams, communicate complex information to diverse audiences and ability to manage multiple projects and deadlines simultaneously.
- Lead, manage, and facilitate an organized approach to capturing and communicating specification status, required actions, and responsible parties required to ensure timely effectiveness of specifications.
Why INCOG?
- Paid time off, based on tenure
- 11 paid holidays
- 401(k) plan with company match up, vested immediately
- Choice of health & wellness plans
- FSA and HSA options
- Onsite wellness facility
- Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations
Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…
Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.
