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Senior Research Scientist
2 weeks ago
The Biopharma Laboratory Manager will lead and coach team members in laboratory operations. This role includes tasks such as scheduling, resource management, technical and compliance related issues.
- Interacts with clients to prepare, review, and approve bids and proposals, scope of work and pricing. Negotiates timelines and pricing with clients.
- Directs work responsibilities of team leaders as well as prioritizes tasks and resources.
- Reviews data for technical quality and compliance to protocols, methods, and SOPs. Reviews and approves laboratory investigation, deviations, and QA facility and data audits.
- Prepares revenue projection reports, reviews Partner and timesheet reports for revenue recognition and billing, evaluates resource utilization reports and project profitability.
- Reviews and approves study protocols, project status reports, final study reports, and other project-related technical documentation.
- Assists in technical sales and marketing, prepares technical marketing materials, and participates in poster and podium presentations in conferences.
- Assists upper management in longer-term planning, budgeting, new capabilities development, and other responsibilities.
- Prepares and implements PPD SOPs and company operational policies. Ensures adherence and makes recommendations for quality system improvements.
- Previous experience providing the knowledge, skills, and abilities to perform the job (comparable to 10+ years) or equivalent and relevant combination of education, training, and experience.
- 5+ years of management responsibility.
- Proven leadership skills.
- Full understanding of laboratory requirements, PPD SOPs, ICH guidelines, USP requirements, and FDA guidance.
- Proven technical troubleshooting analytical instrumentation and problem-solving abilities.
- Excellent written and oral communication skills.
- Project and time management skills.
- Ability to implement quality systems and process improvements.
- Ability to provide guidance to clients on analytical issues and regulatory requirements.
- Knowledge of budgeting, forecasting, and fiscal management.
- Demonstrated coaching and mentoring skills.
- Strong organizational agility and demonstrated drive for results.
