Pharmaron
Associate Director of Analytical Chemistry
Pharmaron, Coventry, Rhode Island, us, 02816
Come Join Our Growing Team!
We are seeking an
Associate Director, Analytical Chemistry
to join our dynamic and growing team in Coventry, RI!
Position Summary:
The Associate Director oversees analytical services including development, optimization, validation and transfer of drug substance-related analytical test methods in alignment with the overall business strategy.
Principal Accountabilities:
Provide input to the scientific strategic direction of the department, including influencing the mission, vision, and culture of the organization in alignment with department/company goals.
Identify best practices directly impacting functional deliverables, and leverage resources to capitalize on them.
Create and encourage a transparent and trustworthy work environment.
Promote the culture that "Quality is everyone's responsibility."
Review RFPs, assist with providing information for the analytical portion of proposals, participate in customer visits, audits, or project meetings.
Ensure both initial and continued personal training is carried out and adapted according to need, and ensure that all employees are suitably trained in all processes before undertaking tasks.
Assist scientific staff in reaching appropriate critical decisions which align with current functional or cross-functional strategies.
Ensure high quality in analytical work and GMP compliance: accurate documentation, instrument qualification, software validation, training, sample handling, testing, record keeping.
Oversee the development/improvement and validation of robust analytical methods that are GMP-friendly based on quality-by-design and document formal protocols and reports.
Oversee method transfer activities, including writing protocols and reports as needed.
Establishment and qualification of GMP-compliant analytical laboratories.
Manage multiple projects requiring analytical or process-related activities.
Establish or revise procedures to cover all GMP activities, as well as harmonizing or integrating with other Pharmaron sites.
Communication with Pharmaron colleagues as well as customers on projects.
Review experimental data, notebooks, and instrument qualification protocols/reports as needed.
Actively participate in investigations, problem-solving, and troubleshooting. Assisting with investigation reports.
Prepare and present data summaries (written and oral) as necessary. Present to cross-functional teams and effectively communicate critical analytical issues and solutions.
Direct the development of SOPs appropriate for CDMO activities.
Communicate openly within the group to provide and gather information, to optimize the use of resources, and to optimize efficiency.
Education and Experience:
PhD with 10+ years of experience in pharmaceutical analysis with 5+ years of management experience or Masters Degree with min 12 years industry experience.
Ability to effectively lead and supervise staff.
Proven technical skills in analytical method development and validation of small molecules.
Proven scientific skill and ability to oversee complex scientific work.
Effective in managing multiple competing activities and delivering to timelines.
Highly commercially oriented, able to demonstrate how delivery excellence can create competitive advantage to deliver and sustain business growth.
Highly organized, but flexible to changing priorities.
Ability to work in a cross-functional environment.
High level of awareness to innovative technologies and ability to adapt to in-house needs.
Broad experience in analytical instrumentation and selected higher end laboratory techniques.
Ability to contribute to multi-disciplinary scientific teams.
Ability to drive continuous improvement.
Working knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidance.
Excellent communication skills, both verbal and written.
Benefits:
Pharmaron cares about our work community and offers a variety of benefits allowing employees the opportunity to customize a benefits package that meets their personal needs. Company benefits include the following:
Medical, Dental & Vision Insurance Plan with Employer Contribution.
Health Reimbursement Account Funded by Employer.
Healthcare & Dependent Care Flexible Spending Accounts.
Employee Life and AD&D Insurance 100% Employer Paid.
Voluntary Life and AD&D Insurance for Employee, Spouse & Child(ren).
Short and Long Term Disability 100% Employer Paid.
401k with Employer Match.
Employee Assistance Program.
About Pharmaron:
Pharmaron is a premier R&D service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities, and established a broad spectrum of research, development and manufacturing service capabilities throughout the entire drug discovery, preclinical and clinical development process across multiple therapeutic modalities, including small molecules, biologics and Cell & Gene Therapy products. With over 19,000 employees, and operations in the U.S., the U.K., and China, Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China.
Pharmaron is proud to be an Equal Employment Opportunity and Affirmative Action employer.
#J-18808-Ljbffr
We are seeking an
Associate Director, Analytical Chemistry
to join our dynamic and growing team in Coventry, RI!
Position Summary:
The Associate Director oversees analytical services including development, optimization, validation and transfer of drug substance-related analytical test methods in alignment with the overall business strategy.
Principal Accountabilities:
Provide input to the scientific strategic direction of the department, including influencing the mission, vision, and culture of the organization in alignment with department/company goals.
Identify best practices directly impacting functional deliverables, and leverage resources to capitalize on them.
Create and encourage a transparent and trustworthy work environment.
Promote the culture that "Quality is everyone's responsibility."
Review RFPs, assist with providing information for the analytical portion of proposals, participate in customer visits, audits, or project meetings.
Ensure both initial and continued personal training is carried out and adapted according to need, and ensure that all employees are suitably trained in all processes before undertaking tasks.
Assist scientific staff in reaching appropriate critical decisions which align with current functional or cross-functional strategies.
Ensure high quality in analytical work and GMP compliance: accurate documentation, instrument qualification, software validation, training, sample handling, testing, record keeping.
Oversee the development/improvement and validation of robust analytical methods that are GMP-friendly based on quality-by-design and document formal protocols and reports.
Oversee method transfer activities, including writing protocols and reports as needed.
Establishment and qualification of GMP-compliant analytical laboratories.
Manage multiple projects requiring analytical or process-related activities.
Establish or revise procedures to cover all GMP activities, as well as harmonizing or integrating with other Pharmaron sites.
Communication with Pharmaron colleagues as well as customers on projects.
Review experimental data, notebooks, and instrument qualification protocols/reports as needed.
Actively participate in investigations, problem-solving, and troubleshooting. Assisting with investigation reports.
Prepare and present data summaries (written and oral) as necessary. Present to cross-functional teams and effectively communicate critical analytical issues and solutions.
Direct the development of SOPs appropriate for CDMO activities.
Communicate openly within the group to provide and gather information, to optimize the use of resources, and to optimize efficiency.
Education and Experience:
PhD with 10+ years of experience in pharmaceutical analysis with 5+ years of management experience or Masters Degree with min 12 years industry experience.
Ability to effectively lead and supervise staff.
Proven technical skills in analytical method development and validation of small molecules.
Proven scientific skill and ability to oversee complex scientific work.
Effective in managing multiple competing activities and delivering to timelines.
Highly commercially oriented, able to demonstrate how delivery excellence can create competitive advantage to deliver and sustain business growth.
Highly organized, but flexible to changing priorities.
Ability to work in a cross-functional environment.
High level of awareness to innovative technologies and ability to adapt to in-house needs.
Broad experience in analytical instrumentation and selected higher end laboratory techniques.
Ability to contribute to multi-disciplinary scientific teams.
Ability to drive continuous improvement.
Working knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidance.
Excellent communication skills, both verbal and written.
Benefits:
Pharmaron cares about our work community and offers a variety of benefits allowing employees the opportunity to customize a benefits package that meets their personal needs. Company benefits include the following:
Medical, Dental & Vision Insurance Plan with Employer Contribution.
Health Reimbursement Account Funded by Employer.
Healthcare & Dependent Care Flexible Spending Accounts.
Employee Life and AD&D Insurance 100% Employer Paid.
Voluntary Life and AD&D Insurance for Employee, Spouse & Child(ren).
Short and Long Term Disability 100% Employer Paid.
401k with Employer Match.
Employee Assistance Program.
About Pharmaron:
Pharmaron is a premier R&D service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities, and established a broad spectrum of research, development and manufacturing service capabilities throughout the entire drug discovery, preclinical and clinical development process across multiple therapeutic modalities, including small molecules, biologics and Cell & Gene Therapy products. With over 19,000 employees, and operations in the U.S., the U.K., and China, Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China.
Pharmaron is proud to be an Equal Employment Opportunity and Affirmative Action employer.
#J-18808-Ljbffr