Analytical Subject Matter Expert

vor 6 Monaten

Basel, Schweiz Sobi Vollzeit

**Key Responsibilities/Scope of the Job**

**Shared responsibilities**:

- Act as analytical lead when appropriate for managing analytical projects under his/her responsibility
- Cross functional interaction/collaboration within Sobi organization.
- Interaction/collaboration with CDMOs/CLOs as required by the projects.
- Act as a technical expert for designing analytical studies and for authoring/reviewing of protocols and reports as required
- Participate in/manage Compliance activities related to (external) manufacturing such as analytical method changes, major/critical deviations, risk assessments and CAPAs.
- Issue, review and approve applicable internal and external SOP’s and analytical instructions.
- Ensure all activities are carried out according to applicable regulatory guidelines as well as Sobi’s global quality and safety standards.
- Contribute during set up of new analytical specifications and stability programs and review changes thereof.

**CMC Development Responsibilities**
- Analytical Subject Matter Expert for DS/DP development activities (analytical support for process characterization, PPQ campaign, release, stability program, product characterization, specification, reference standard).
- Act as a technical expert for CMC sections (module 3) of regulatory submissions and responses to agency questions/requests for analytical topics on DS/DP.

**AS&T responsibilities**
- Actively participates as main SME as part of LCM (e.g: revision of specification, methods changes, stability program).
- Write and review applicable sections of the APR/PQR/YBPR.
- Write and review applicable sections in registration files due to variations, market expansion and annual reporting.
- Actively participates as analytical technical SME to support commercial manufacturing of DS/DP processes at external manufacturers for Sobi projects.
- Maintenance of critical reagents (including refeence standard material)

Education/Learning Experience/Work Experience
- Required:_
- Master in Biotechnology or equivalent. PhD is a plus.
- 10 years plus experience within pharmaceutical industry
- 5 year experience within CMC development activities
- Experience in working with C(D)MO’s and CLO’s.
- Experience within Quality control/GMP manufacturing is an asset
- Profound knowledge of protein and of related Drug substance manufacturing processes (knowledge of Drug Product process is a plus)

Skills/Knowledge/Languages
- Required:_
- Recognised analytical expert.
- Experience in analytical development, optimisation/troubleshooting, product characterisation, release testing, stability studies for late stage development and commercial products.
- Demonstrable experience of working in cross functional team with ability to multi task, prioritise and be an effective decision maker.
- Experience with main regulatory guidance’s pertaining to the Chemistry, Manufacturing and Control of manufacture pharmaceutical products and regulatory authorities communication.
- Excellent verbal and written communication skills in English; French, Swedish and/or German are a plus.

Personal Attributes
- Required:_
- Excellent understanding of development and GMP processes and challenges
- Problem solving, creative, flexible with regards to evolving priorities
- Organised, detail oriented and structured working style
- Deliver results in a complex business network
- Perceive change as an opportunity for improvement and successfully manage ambiguity
- Recruitment contact & how to apply_
- Sobi is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, or national origin. Sobi is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities in employment, its services, programs and activities._

**Why Join Us?**

We are a global company with around 1,500 employees in more than 30 countries, and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.

**Sobi Culture**

At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceuti

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