JOB SUMMARY

To support our rapid growth, we are seeking a highly talented and motivated Supervisor, Quality Control (QC) Analytical Development to join our organization.

The Supervisor, QC Analytical Development will be responsible for the oversight of day to day activities in support of the Analytical Research and Development programs for Quality Control.

This role will require a high level of customer service, collaboration and cross functional support for quality control, including interactions with external customers.

The ideal candidate will be an innovative leader with experience in Analytical Development and Quality Control environments.

JOB DUTIES

• Actively partners with Project management, Operations, Quality Control and Quality Assurance to ensure completion of activities within required timelines are met.
• Supervises a team of 8-10 direct reports.
• Responsible for developing and implementing analytical development strategies to achieve optimal results.
• Identifies analytical science capabilities and technology tools needed to enable method development, QC testing, and new drug introduction / support.
• Applies scientifically-driven thinking to the development of scientifically sound, well understood, and phase appropriate analytical methods for development compounds;

raw materials, intermediates, drug substances and drug product.

• Supervises analytical activities for method development, validation and transfer.
• Reviews technical documents and data review for method transfers / validation
• Provides support and contributes to other analytical activities as necessary.
• Attends client specific meetings for discussion pertaining to method transfer and validation activities.

PROFESSIONAL SKILLS

• Possesses superior attention to detail as well as the ability to work in a cross-functional team environment.
• Excellent organizational skills and the ability to work within a fast-paced environment
• Multi-disciplinary knowledge of Quality Control
• Exemplary capability for logical, analytical, and strategic thinking
• Problem analysis and resolution skills required
• Experience working in a laboratory under cGMP, ICH, USP, and global compendial regulations and guidance, particularly as related to analytical method development and validation
• Excels at presenting technical data in a clear and concise manner while representing the QC analytical development team in cross functional meetings.

Capable of influencing with sound scientific rationale.

• Scientific technical writing ability including authoring and revising SOPs, method transfer protocols, technical reports, and investigations.
• Skilled at troubleshooting of assay and equipment issues

EXPERIENCE

5-10 years of relevant working experience in analytical development in pharmaceutical industry. Being skilled in the application of cGLP / cGMP is desirable;

2 years of management / leadership responsibilities

• Extensive analytical development background with working knowledge of chemistry, analytical or pharmaceutical science and QC experience.
• Proficiency with performing analytical testing using the following types of equipment : HPLC / UPLC, GC, FTIR, UV / VIS, Karl Fisher, Particle Size Analyzer, Osmometer, pH is required.
• Detail-oriented. Ability to critically evaluate analytical data from a broad range of scientific disciplines.
• Experience working in a CMO environment is preferred.

EDUCATION

Bachelor’s degree in analytical chemistry or equivalent.

QUALITIES

• Advanced interpersonal skills with ability to influence team
• Excellent communication skills both oral and written
• Demonstrated advanced capability for multi-tasking in a dynamic environment with changing priorities
• Highly resilient can quickly move forward despite challenges
• Maintains a positive outlook, able to work in a highly collaborative environment while balancing independent thinking.
• Honesty, integrity, respect and courtesy with leadership and peers
• Strong commitment to conducting PCI business according to the highest legal and ethical standards, and to continually pursue excellence in the manufacturing and delivery of PCI products and services
• A thirst for knowledge, expected to stay informed of industry advances and bringing those ideas to the team.

PHYSICAL REQUIREMENTS & MENTAL DEMANDS

• Routine work requires walking, standing, bending, reaching, climbing stairs, lifting or carrying objects that typically weigh less than 20 lbs.
• Capacity to work on several tasks simultaneously.
• Able to organize and prioritize work activities.
• Must be able to walk and drive between locations
• Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves
• Comfortable with working / handling of hazardous materials

COMMUNICATIONS & CONTACTS

Interacts with all departmental staff to coordinate activities.

MANAGERIAL & SUPERVISORY RESPONSIBILITIES

• Manages and develops direct reports.
• Assigns responsibilities and duties within the group
• Provides constructive feedback to team and authors performance reviews within corporate timelines

TRAVEL

• Must be able to walk and / or drive between NH locations
• Some domestic travel may be required,

LI-LL1

Join us and be part of building the bridge between life changing therapies and patients.

Last updated : 2024-04-22