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Associate Director

Pharmaceutical Product Development (PPD)

Cambridge, Massachusetts, United States of America

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.

Our teams support career growth whether you are looking for long term opportunities within the scientific ladder, to pursue project management, or develop into a leader -- these are just a few career pathways available once your become a part of the Thermo Fisher's Clinical Research Group team. 

To learn how Thermo Fisher's Clinical Research Group can advance your career, apply now!

Summarized Purpose:

Supervises and assists group leaders, scientists, and medical technologists in laboratory operations with tasks such as scheduling, resource management, technical and compliance related issues. Plans, directs and implements improvements in systems, processes and procedures to increase efficiency, productivity and quality in the laboratory. Assists the division director in strategy, business development and expansion initiatives by providing mid-range (1-3 month) resource utilization predictions for a department.

Essential Functions

  • Interacts with clients and business development on requests for proposals and project definition. Prepares, reviews and approves bids and proposals, scope of work and pricing. Negotiates with clients on timelines and pricing.  

  • Manages/directs work responsibilities of group leaders as well as prioritize talks 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. Leads client and regulatory audits.  

  • Prepares and updates 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 technical conferences.  

  • Assists upper management in strategic planning, budgeting, new capabilities development and other responsibilities.  

  • Prepares and implements PPD SOPs and company operational policies. Ensures adherence and makes recommendations to quality system improvements.

Minimum Qualifications - Education and Experience:

  • 10+ years of previous experience that provides the knowledge, skills, and abilities to perform the job or equivalent and relevant combination of education, training, & experience.  

  • 5+ years of management and leadership responsibility

  • Bachelor's degree in Chemistry or related field or equivalent

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills and Abilities:  

  • Full understanding of laboratory requirements, PPD and client 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  

  • Demonstrated strategic planning skills  

  • Strong organizational agility and demonstrated drive for results

Work Environment:

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. 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.

Our 4i Values:

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.

#StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Job posted: 2024-04-26

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