Senior Analytical Development Leader (M/F)
March 28, 2023
MedinCell® is a pharmaceutical company at premarketing stage that develops innovative long-acting injectable medicines in many therapeutic areas based on our BEPO® technology.
We are looking for our Senior Analytical Development Leader.
Senior Analytical Development Leader
The Senior Analytical Development Leader oversees the Analytical Development and Quality Control unit and define and implement its strategy.
The unit is accountable for:
- Developing analytical methods to support Research and Development activities ;
- Qualifying analytical methods developed to support in-house and external manufacturing and testing activities, on a fit for purpose level ;
- Performing sampling and quality control on in-house manufactured products ;
- Managing the laboratory equipment used by the analytical development team ;
- Providing MedinCell’s programs with stability studies, coordinated data, reports and products specifications ;
- Providing other MedinCell teams with appropriate expertise.
Your missions at MedinCell
Analytical activities:
- Provide leadership and analytical strategy for MedinCell in the planning and execution of all Analytical Method (AM) Development activities, in support of development projects; Define the strategic analytical pathways at each development step in close alignment with the Innovation and Development team, Non-Clinical Development and Regulatory Teams as well as with the other Pharmaceutical Operations teams;
- Define and implement Analytical Development work plans including objectives, milestones and deliverables ;
- Include expert knowledge and advice, scientific and regulatory considerations, as well as strategic business needs into the design and implementation of Analytical Development plans ;
- Provide appropriate resources to support the management of laboratory equipment included maintenance and to ensure relevant training ;
- Develop fit-for-purpose AM for all development steps, from Lead Formulation Selection to Clinical Phases and monitor their potential changes ; Perform AM qualification fit for purpose to each stage of the projects ;
- Be responsible of the products specifications supporting the projects ;
- Oversee and organize sampling and testing of incoming raw materials, intermediates and drug products manufactured in-house ; Manage quality control activities in compliance with corresponding procedures, standards and guidelines;
- Support transfer of AM packages to manufacturing and testing sites and development partners ;
- Ensure that internal (in-house) and/or external (contracted) ICH Stability studies are performed properly .
Team Management
- Attract and retain talents;
- Set-up and review annual goals for the team;
- Perform regular and yearly performance assessment;
- Set-up annual training needs for the team;
- Act as a coach and mentor for team members;
- Manage activities in a matrix organization and ensure cross department activities are efficient;
- Ensure regular feedback is provided.
Your profile
Education and background
- Ideally Pharm D or Engineer degree with a PhD in Chemistry, Pharmaceutical Science, Analytical Sciences;
- Expertise in many analytical technics, equipment, and methods;Minimum 15 years of experience in Analytical Development in Pharmaceutical Industry with a significant experience in injectable Pharmaceutical Products;
- Strong hands-on experience in all phases of Pharmaceutical Development from Early Stage to approvals and Post-Marketing variations;
- Experience in working in pharmaceutical development partnerships such as co-development agreements;
- Expert knowledge of drug development processes and regulations, especially for injectable Pharmaceutical Products.
- Experience in polymer-based drug delivery systems (DDS) is a plus.
Skills and requirements
- Fluent in English, spoken and written: ability to attend complex meetings and write reports;
- French language would be a plus;
- Strong knowledge in regulatory requirements, pharmaceutical guidelines, and international standards, mainly in injectable products;
- Experienced in sampling and testing raw materials and drug products;
- Results orientation with focus on timely delivery and sense of urgency;
- Effective functioning in a rapidly evolving environment and adherence to the values, principles, and mission of the company;
- Ability to make choices within budget and priorities;
- Highly collaborative cross-functional approach;
- Active involvement in Continuous Improvement.