Biopharma Supervisor, Technical Writer and QC Review

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

Basic Function and Scope of Responsibility: The BioPharma Technical Writer and Quality Control Reviewer Supervisor is primarily responsible for needed technical writing of the BioPharma Research and Development Team. Additionally, the supervisor will direct the activities of technical writers and Quality Control Reviewers and ensure that the overall team performance meets required objectives.

Qualifications

Essential Job Duties:

• Leads Technical Writing and Quality Control Reviewing teams including scheduling oversight.

• Provides leadership and supervision for Technical Writers and Quality Control Reviewers and for projects that these associates are contributing to ensure program productivity and efficiency.

• Work closely and effectively with R&D, Laboratory Operations, Technical Operations, and Project Management teams to ensure that technical writing and Quality Control Reviewing tasks are progressing and milestones are achieved pursuant to organization and/or client timelines.

• Commitment to high quality of work and productivity.

• When appropriate, identify and develop training programs for Technical Writers and Quality Control Reviewers.

• Promote a culture of continuous learning by mentoring and training others and by participating in continuing education and training programs.

• Plan, develop, organize, write and edit forms, protocols, reports, procedures and technical aspects of internal and external written communications and publications.

• Implement / enhance sound practices in technical writing.

• Analyze documents to maintain continuity of style of content.

• Manage updates and revisions to technical documents.

• Manage and direct activities of direct report through effective hiring, onboarding, training, and supervision of work activities.
• Conduct regularly scheduled one-on-one meetings with direct report focused on performance goals, progress, and career growth and development.

• Assess team member by conducting effective performance reviews, and coaching through necessary performance improvements as needed.

• Conduct regular team meetings and/or provide regular communication to team members.

• Serve as an escalation point within the BioPharma R&D and Technical Operations teams for regulatory questions.

• Assist in key activities supporting quality within the BioPharma R&D and Technical Operations teams:

o Aid implementing quality systems related to pre-validation and validation (e.g., Electronic Lab Notebook, proper utilization of NCE reporting software, approaches to quality control, etc.).

o As needed, aid in identifying and tracking patterns in pre-validation / validation deviations

• Other duties as assigned by BioPharma Services R&D management

Essential Knowledge, Skills and Abilities:

• BS or BA in biological, physical, chemical, or clinical laboratory science. 4 years’ experience in a biological laboratory setting preferred

• Goal oriented, with excellent time management and organizational skills

• Excellent interpersonal skills, with ability to interac