Full-time
Sobi Location: Sweden
Company Description
Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.
Job Description
The Group Lead Analytics in Science and Technology (SAT), will oversee a team of scientific experts specialized in Analytics of Small and/or Large Molecules.
This leadership role is pivotal in ensuring technical excellence, regulatory compliance, and the continuous improvement of manufacturing processes. The incumbent will drive cross-functional collaboration to support the launch and lifecycle management of products, technology transfers, and the implementation of innovative methodologies.
Key Responsibilities/Scope of the Job
- Leads the Analytical team Subject Matter Experts (SMEs) on associated science and technology related topics.Serve as the primary point of contact for coordinating team efforts, resource planning, and task allocation.
- Drive the strategic planning process for the Analytical team, including identifying areas for improvement, resource optimization, and budget management.
- Accountability for analytical method validation for Sobi products.
- Oversight on CMO/CLO activities in regards to analytical processes together with the SMEs for Analytics.
- Lead and oversee launch, transfer and lifecycle activities associated with analytical testing and takes responsibility for timely ad compliant execution of those activities.
- Issue, review and approve applicable internal and external SOP’s and manufacturing instructions.
- Ensure the development & knowledge of the analytical team experts
- Deputize the Head of Science and Technology when required.
Qualifications
Position Qualifications
- Advanced degree (MSc or PhD) in Analytical Chemistry, Chemistry, Biology, Biotechnology, Pharmacy or similar.
- Minimum of 8 years of experience in the pharmaceutical industry in the field of quality control or quality assurance, experience with GMP-compliant analytics.
- In depth experience in leading of teams.
- Demonstrable experience of leading and working in cross functional teams with ability to multi task, prioritize and be an effective decision maker.
- Scientific and technical background of CMC development and GMP requirements in pharmaceutical analytics.
- Recognized expert with analytical methods and transfers.
- Comprehensive understanding of cGMP, as well as profound knowledge of local and international GMP regulations.
- Proven track record of successful analytical transfers and method validations.
Personal Attributes
- Fullfillment of all of Sobi CARE values
- Ability to act independently and take initiative.
- Excellent communication skills in fluent English.
- Strong team player and integrative personality, able to build trust and effective relationships with a wide range of partners.