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Job Details

Associate Director/ Director Quality Control

Company name
Ipsen Biopharmaceuticals, Inc

Location
Cambridge, MA
4 hit(s)  

Profile


Ipsen Biopharmaceuticals, Inc

Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.

Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned.

Company Profile

Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care, and with a rich heritage in consumer healthcare.

We aim to make a sustainable difference by significantly improving patients' health and quality of life and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in oncology, neurosciences and rare diseases.

The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make the difference. We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions; leaders drawn by a purpose to make a direct impact through their work in people's lives.

We offer employees a wealth of fulfilling challenges & growth opportunities, and the chance to contribute within a fast-moving organization, an organization that is genuinely game-changing.

Position Summary:

Responsible for overseeing product and raw material specifications, raw material testing, in-process, bulk, and drug product release testing, stability testing and trending, environmental monitoring of GMP production and sampling areas, GMP compliance of all lab activities, and support/authoring of QC related CMC regulatory sections.

Responsibilities:

  • Provide leadership and direction to Quality Control managers and support team to ensure high quality service. Drive continuous improvement.
  • Responsible for building effective systems, processes, teams and managing through them for a smooth lab operation
  • Oversee the day to day operations of the Quality Control laboratory and stability program to ensure accurate results, adherence to company protocols and timely completion of projects
  • Provide key leadership, vision and direction to the QC Lab while providing operational and technical expertise.
  • Manage and develop direct reports by setting clear expectations and resolving conflicts.
  • Establish department operation schedule, plans, processes, budgets, departmental strategies, goals, objectives and metrics. Business continuity and long-term planning.
  • Provide technical expertise for personnel training, deviations, CAPA, inventory management, CGMP compliance and data trending
  • Prepare and review documentation required for regulatory submissions
  • Lead lab support topics in inspections conducted by external regulators and business partners
  • Maintain metrics for the QC function and continuously improve the area in terms of quality, efficiency and effectiveness.
  • Ensure the laboratory remains current with all changes to applicable compendia, regulations and guidance.


Skills & Requirements


Education:
  • Bachelors Degree in Biology, Chemistry, or related field is required.
  • Advanced degree in Biology or Chemistry is preferred.

Technical Skills and Experience:
  • 15 years of GMP experience in the pharmaceutical/ biotechnology industry
  • In depth knowledge of analytical quality control procedures, and the application and interpretation of GMP regulations and compendia requirements.
  • Knowledge of laboratory equipment, instrumentation, and techniques in both chemistry and microbiology
  • Extensive experience with analytical method validation and qualification of equipment and systems
  • Experience building and growing an organization into a high performance team
  • Experience implementing lean and Six Sigma solutions into a laboratory
  • Knowledge of biotech bulk and finished product manufacturing is highly desirable
  • Extensive knowledge of US and EU cGMP regulations and guidance
  • Extensive and proven experience in FDA inspection preparation and management
  • Demonstrated leadership, interpersonal, communication, and motivation skills.

Ipsen Bioscience, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process.https://analytics.click2apply.net/vzB5nbDHGmWKMuAeDSAarL>

PI102460212

Company Profile

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