Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Head of CMC & Pharmaceutical Development - Netherlands

Company: Barrington James Europe
Location: Netherlands
Reference: EM-HEADOFCMC
Closing Date: 05 May 18
Type: Permanent
Salary (£): Competitive
Benefits: Competitive

Job Summary:

Head of CMC & Pharmaceutical Development - Netherlands - Dutch speaking

Requirements:

Barrington James are exclusively retained with a small yet very experienced consultancy firm specialising in the development and registration of veterinary pharmaceuticals in Europe. As a consultancy they operate within a state-of-the-art pharmaceutical development laboratory, enabling them to develop a wide range of formulations in-house. This position works closely with both the Regulatory Affairs & Development functions internally to develop both new and generic veterinary medicines.

Job Summary:

The organisation are looking for a talented individual to lead the Regulatory Affairs and Pharmaceutical Development group. The objectives of this role are to design formulations, optimize processes, select and work with CMOs, oversee scale-up activities, write regulatory documents, and contribute to the overall pharmaceutical development activities – from preformulation to commercial drug product manufacturing and Regulatory Affairs – in multiple projects.

Key responsibilities:

  • Provide technical leadership in formulation development (in-house and external) and manufacturing activities of external partners (CMOs).
  • Evaluate, recommend, and direct outsourced API and/or drug product development with CMOs to complete formulation development; negotiate and manage contracts; build effective on going relationships.
  • Develop and execute project plans to support overall development objectives.
  • Work in a multidisciplinary team to develop optimal formulations meeting both pharmaceutical and end-user (veterinarian, animal owner) requirements.
  • Support (EU) regulatory submissions by preparing, reviewing and/or approving CMC sections (Part 2) of the dossier (including ASMFs), and ensure compliance with current regulatory requirements.
  • Prepare responses to regulatory authority information requests during the review process to ensure product approvals.
  • Maintain current knowledge of relevant regulations.
  • Lead, develop, coach and evaluate a team of experienced pharmaceutical development analysts.
  • Occasional travel required for interactions with clients, CMOs and other external partners.

Qualifications:

  • MSc degree in Pharmaceutics, Chemistry or comparable scientific degree with a minimum 5 years of experience in the Pharmaceutical industry. Candidates with a BSc degree and extensive industry experience will also be considered.
  • Experience in building and managing pharmaceutical formulation development and manufacturing using internal and external resources.
  • Broad understanding of various formulation approaches, drug delivery methods, and routes of administration.
  • Knowledge of EMA regulations, (V)ICH guidelines and GMP to provide regulatory guidance to the development team.
  • Experience leading drug development teams is a plus.
  • Strong written and verbal communication and interpersonal skills.
  • Fluent in Dutch and English
  • Ability to work on multiple projects at the same time.
  • Hands-on individual with a collaborative personal style and the ability to work well in a fast-moving, multidisciplinary team.
  • Highly-motivated, organized, and detail-oriented.

Apply for this job: Head of CMC & Pharmaceutical Development - Netherlands

Contact Information:

Address:  Head Office
Rowan House Smallfield Road Horley Surrey
RH6 9AU
England
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.