# Technical Operations Manager – SME Sterile Manufacture at Hameln Pharma

> United States · Manager · Other · open. Source: https://alderhq.app/jobs/personio%3Ahameln-pharma%3A2752827 (read 2026-11-12).

## Facts (observed)

- Company: [Hameln Pharma](https://alderhq.app/companies/hameln-pharma)
- Location text: Hameln (DE)
- Where it can be done from (inferred): United States (evidence: "Location: Hameln (DE)")
- Posted: 2026-08-13 (91 days ago)
- First seen by alder: 2026-11-04 · last verified: 2026-11-08
- Reposted: 0 times · edited: 0 times
- Apply on the employer's site: https://hameln-pharma.jobs.personio.de/job/2752827

## Pay and sponsorship

- Posted pay: not posted
- Licensed UK sponsor: registered as "HAMELN PHARMA LTD" (checked 2026-11-09, [register](https://www.gov.uk/government/publications/register-of-licensed-sponsors-workers))

## Description (the employer's text)

### Your mission

- In your role as a Subject Matter Expert (SME) for the transfer of parenteral products, you prepare product-specific risk assessments to evaluate the technical feasibility and implementation at the respective contract manufacturing organisation (CMO).
- You define Critical Material Attributes (CMAs), Critical Quality Attributes (CQAs), and the resulting Critical Process Parameters (CPPs) in accordance with relevant guidelines.
- You play a key role in the preparation of master documentation for product transfers, working closely with our international Regulatory Affairs department.
- You evaluate data and documentation generated during product transfers and derive the necessary GMP-compliant conclusions and corresponding actions.
- Your responsibilities also include supporting the investigation and handling of quality-related deviations during transfers in close collaboration with the Quality department.
- You coordinate commercialisation-related aspects of product transfers with the Supply and Sales department.
- In addition, you provide backup support for the administrative requirements of product transfers, such as purchase order creation and invoice processing, as well as the electronic filing and management of documentation.
### Your profile

- You have many years of experience as a Manufacturing or Line Manager, as an Expert in Qualification, Validation or Process, or with comparable qualification in the production environment of sterile medicinal products.
- Knowledge of regulatory documentation (CMC dossier / eCTD Module 3), requirements, and procedures is an advantage.
- You have experience in project management and work in a well-structured, highly diligent, and solution-oriented manner.
- You communicate confidently in both German and English; proficiency in an additional foreign language would be an advantage.
- You are confident in using standard MS Office applications and are familiar with tools such as Copilot.
- You have strong communication and teamwork skills, a commitment to continuous professional development, and the flexibility to spend part of your working time at other locations within the company group.
### Why us?

- Comprehensive, industry-specific onboarding and independent work in your field of reaponsibility
- A good work-life balance thanks to flexible working hours and the option of mobile working
- 30 days' vacation and time off in special life situations
- Fair, attractive remuneration as well as a company pension allowance and capital-forming benefits
- Individual training opportunities and support for professional and personal development
- An attractive, modern working environment with ergonomic workstations and the option to lease a job bike
- EGYM Wellpass for a wide range of sports and wellness activities
- Discounts at numerous shops and brands through our corporate benefits
- Bistro offering hot meals and meal subsidies
- Company celebrations, such as family summer parties and annual kick-off events

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Data: alder (https://alderhq.app). Cite https://alderhq.app/jobs/personio%3Ahameln-pharma%3A2752827 and the date you read it. Observed facts come from the employer's own listing; location reach, level, family and skills are inferences.