FSP - Associate/Group Leader

Work Schedule

Environmental Conditions

Job Description

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

Key responsibilities:

• Provides on-site management and direction to laboratory staff and resources for project activities and needs, oversee daily operations to monitor quality and project timelines, and assist in preparation and implementation of company policies, quality systems and training programs.
• Coordinate with client’s project lead(s) to define analytical work packages (i.e., method development/validation, reference standard characterization, batch release and stability testing for biologic drug substances/drug products) and schedule activities within your analytical team.
• Review and verify experimental data/electronic lab notebook experiments for formulation/process development samples and clinical trial supplies (e.g. cGMP compliant stability and batch release testing) for drug substances and drug products.
• Training of junior staff on new analytical techniques and revised analytical procedures.
• Author and/or review method protocols/validation reports, stability protocols, technical memos and other lab reports.
• Mentor junior staff in experimental design for method development and validation activities.
• Mentor junior staff in troubleshooting of equipment and experimental problems.
• Encourage ideas for continuous improvement activities and initiatives within work group.
• Understand and adhere to corporate standards regarding code of conduct, safety, and GXP compliance.

Education and Experience:

• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
• AGL: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 6 years’)
• OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 4 years’)
• OR PhD and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 2 years’)
• GL: · Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years’)
• OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 6 years’)
• OR PhD and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 4 years’)

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Validated leadership skills and proven ability to perform supervisory tasks
• Ability to manage daily operations for a team of approximately 9 direct reports
• Experience in analytical methodology, such as chromatography (HPLC and GC), KF, UV and compendial methods
• Experienced in laboratory systems (LIMS, CDS, ELN) preferred.
• Ability to cultivate a collaborative work environment within a team
• Ability to troubleshoot multiple systems/methodologies
• Ability to independently optimize analytical methods
• Understanding of basic financial terms and definitions as it applies to the business
• Understanding of proposal and project scope as it relates to pricing, resource management and the impact on business

Working Environment:

Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary and/or standing for typical working hours.

Able to lift and move objects up to 25 pounds

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technology with

proficiency.

May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!