The role
You will own the chemistry, manufacturing and controls regulatory strategy — the part of a filing that connects directly to what happens on the plant floor.
What you will do
- Lead CMC regulatory strategy across the product lifecycle
- Author and review CMC sections of submissions and variations
- Assess manufacturing changes for regulatory impact and drive the filing strategy
- Partner closely with manufacturing, quality and process development
- Manage agency questions relating to product quality and manufacturing
What success looks like at 12 months
Manufacturing changes are filed on the right path first time, plant colleagues consult you before changes rather than after, and no supply decision has waited on regulatory ambiguity.
What we require
- Significant CMC regulatory experience with biologics
- Working understanding of GMP manufacturing and process validation
- Experience authoring Module 3 content
- Ability to translate between plant reality and regulatory expectation
What we would like, but will teach you
- Post-approval change management experience
- Experience supporting a facility inspection
- Prior time working in manufacturing or quality
If you meet the required list, apply. We cap the preferred list at four items on purpose, and we would rather read an application from someone who is 70% there and hungry.
Hybrid — onsite at Devens, MA three days a week (Tuesday, Wednesday and one team-chosen day).
Pay and rewards
This role sits at grade 10, with a base range of $165,000 – $213,000 for this location, plus annual bonus, retirement contributions of up to 9%, and day-one benefits. See the full package.
About the site
Our largest manufacturing site, running drug substance 24/7. More about our locations.
Accommodations
Need an adjustment to apply or interview? Email accommodations@ingenbiotech.example. It goes to a separate team and is never shared with the hiring manager. What we can arrange.
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On a live InGen careers site this button would open a one-page application: a CV and three short questions, about twelve minutes, no account required and no cover letter.