Associate Director, PPD Clinical Operations
Our client is a global biotherapeutics company. They have asked us to assist them in a search for an Associate Director, PPD Clinical Operations.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Provides scientific leadership and project management for multiple early-stage development projects.
- Takes ownership responsibility for the successful completion of manufacturing campaigns. Manages pilot plant operations and prioritize production schedule to support multiple company projects.
- Oversees downstream purification processing activities.
- Provides direction, guidance, coaching, and performance management as appropriate and hires additional staff as needed.
- Leads the team who generates and approves technical documents.
- Promotes a center of excellence with a focus on delivering clinical trial material and driving for continuous process improvements.
- Complies with GMPs. Coordinates activities to assist with manufacturing, process development, operation support, and new product development.
- Prepares for Regulatory Agency inspections and internal quality; serves as the lead manufacturing contact.
- Assists in the preparation of the annual operating budget and monitor and control costs.
- Ensures high safety standards within the areas of responsibility are considered and adhered to as governed by local, state, and federal regulations, laws, and policies as well as the company’s policies and directives.
- A postgraduate degree (MS or PhD) is highly preferred.
- At least 3 years of relevant industry experience is required.
- A thorough understanding and extensive practical experience with GMP quality systems and procedures is required.
- Must have a thorough grasp of Regulatory guidance such as FDA, EMA, and ICH.
- Experience establishing specifications of new products is required.
- Pilot-scale process and data analysis skills are required.
- Requires strong knowledge and experience of raw material options, suppliers, and quality requirements.
- Must have the ability to work independently and in cross-functional teams.
- Must have experience with leading teams and overseeing transfer of product from development scale to full manufacturing.
- Must have excellent organizational and interpersonal skills, technical writing, and oral communication skills.
- Proven leadership and track record of successful development and process improvement projects is required.
- Must have mentoring skills to facilitate knowledge sharing.
- Problem solving abilities, creativity, efficient time management, analytical and conceptual thinking are required.
- Must be able to network effectively.
- Must have the demonstrated ability to work within and contribute to highly effective teams.
- Experience working in cross-functional, multicultural, and international teams is required.
- Must have experience in project work and excellent analytical skills.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms
and Forbes' list of Top 200 Best Executive Recruiting Firms