Job Detail

Polyphor is a clinical stage biopharmaceutical company based in Allschwil, Switzerland, and is
focused on the discovery and development of antibiotics and other specialty pharma products
for severe or life-threatening diseases.
Polyphor’s CMC Team is responsible for regulatory and technical CMC and closely involved in
the clinical trial supplies and management of CDMOs. Transitioning from late clinical stage to
commercial phase, Polyphor plans to expand the CMC Team with a hands-on, highly motivated
Senior CMC Specialist

The Senior CMC Specialist is a distinct expert in CMC with core expertise in regulatory CMC,
rounded up by excellent knowledge of technical CMC, GMP manufacturing and supply chain
management.
Responsibilities:

• Plan, prepare and review CMC documents for submissions to competent authorities in the
  course of CTAs (Q-IMPD, IND) and product registrations (MAA, NDA).


• Prepare and participate in CMC-relevant interactions with NCAs (with focus on FDA, EMA)
  like responding to queries and attending regulatory meetings.


• Ensure that CMC documents are accurate, complete, verifiable and in compliance with
  regulatory requirements.


• Maintain current knowledge of the relevant guidelines and regulations.


• Monitor, analyze, and disseminate intelligence on regulatory CMC matters that may affect
  ongoing development programs.


• Work closely with internal and external QAs in the areas of release, production, disposition
  etc. of drug substances and drug products.


• Effectively manage of external partners and outsourced activities, like consultants, contract
  manufacturing, analytical testing, packaging, labeling and distribution operations.


• Review and approve MBRs and PBRs from manufacturing activities, and reports from
  analytical release testing, stability studies and deviation investigations, as required.


• Support the development of production plans and budgets.


• Represent the CMV department as member of multi-functional project teams.


• Report to the Head CMC.

Qualifications & relevant experience:

• MSc, preferably Ph.D., in chemistry or pharmaceutics, ideally complemented by a degree
  or certificates in CMC/ GMP/ RA.


• Minimum of 5, ideally 10, years of experience in CMC, particularly late stage development
  and early commercial phase.

Polyphor Ltd | Hegenheimermattweg 125 | 4123 Allschwil | Switzerland
T + 41 61 567 16 00 | info@polyphor.com | www.polyphor.com

• In depth knowledge of the CMC/ RA/ GMP-related laws and regulations (EudraLex,
  USC/CFR) and guidelines (ICH, EMA/CHMP, FDA and PIC/S).


• Track record of submissions for clinical trials (Q-IMPD, IND) and product registrations
  (MAA, NDA) to the leading competent authorities (FDA, EMA/CHMP, EU NCAs).
  Advantageous is experience with accelerated pathways. A further plus is experience with
  Asian NCAs, in particular NMPA.


• Has prepared briefing books and participated in meetings with NCAs (e.g. SA/ EoP2/, Pre-
  NDA meeting).


• Quality assurance know-how especially in terms of handling changes and deviations
  throughout the development process.


• Experienced in effectively selecting and qualifying CDMOs and managing projects with
  them and other eternal partners.


• Advantageous is knowledge and experience with parenteral dosage forms and synthetic
  peptides.

These specific requirements are supplemented by your excellent understanding of the entire
drug development process and of CMC, regulatory and quality requirements.
You are an excellent and proven team player, have strong managerial and communication skills
and can work effectively in a cross-functional environment. You are highly proficient in analyzing
and critically reviewing CMC, regulatory and scientific data. You have good negotiation skills and
you are fluent and professional in English (written and oral communication), additional languages
are an asset – particularly French and German.

Please send your full application documents to the following address: hr@polyphor.com.
Direct applications are preferred. For further information about the offered position, please
contact Franziska Müller or Karsten Marx, with the email address indicated above.
Polyphor Ltd | Hegenheimermattweg 125 | 4123 Allschwil | Switzerland
T + 41 61 567 16 00 | info@polyphor.com | www.polyphor.com