Manager, QC Stability

Location
Cambridge, MA, United States
Posted
Aug 07, 2018
Ref
478643
Discipline
Quality, Quality Control
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Title:
Manager, QC Stability

Company:
Ipsen Bioscience, Inc.

Job Description:

Position Summary

Under the direction of the Head of QC the QC Stability Manager will contribute independently and strategically. He/She will plan and implement initiatives for stability program. Additionally, the QC Manager will oversee Ipsen's stability program for compliance with Stability ICH/FDA/EMA Guidelines. This role will provide leadership to QC analysts and specialists.

Responsibilities

Responsibilities will include, but are not limited to, the following:
  • Oversee all aspects of stability study execution
  • Contribute to the development of relevant SOPs, protocols, reports and stability sections for regulatory submission
  • Work closely with Manufacturing, Quality Control and Quality Assurance to scheduleand coordinate activities required to execute product stability studies
  • Work closely with Regulatory and Clinical Operations to coordinate activities required to support product throughout clinical studies
  • Serve as a technical lead for, and contribute to writing of, stability related Quality Incidents, Deviations, Investigations, CAPAs and Change Controls
  • Perform data review and statistical analyses to establish, extend and/or support expiration dates
  • Work closely with vendors to expense and manage outsourced testing


Qualifications

Education & Certifications
  • BA, BS or MS in Biology, Biochemistry, Pharmaceutical Science or related discipline

Experience
  • At least 5 years' experience in biopharmaceutical product stability with experience overseeing a stability program.
  • 10+ years of recent professional experience in a QC lab with 2-4 years supervisory experience
  • Experience drafting stability protocols, writing stability sections for regulatory filings with a strong understanding for the guidelines
  • Expertise in stability guidance documents, GMP documentation and pharmaceutical quality systems
  • Proficiency with Microsoft Word, Excel, JMP and PowerPoint
  • Experience with biological and/or chemical assays preferred
  • Experience with analytical equipment troubleshooting preferred
  • Knowledgeable in most or all the following techniques: Particle Size, Peptide Map, Reverse Phase, SEC, CEX, SDS-PAGE, Bioanalyzer, pH, Osmolality and other standard wet chemistry methods.

Core Competencies
  • Ability to work with minimal supervision as well as in a team environment
  • Strongorganizational and presentation skills
  • Strong relationship, teambuilding, customer-focused orientation coupled with the ability to deliver results and meet or exceed agreed-upon objectives and timeframes:
  • Personal flexibility and a proactive orientation;
  • Ability to handle multiple priorities.
  • Ability to work under time and resource constraints.
  • Commitment to excellence and high standards.


Communication & Interpersonal Skills
  • Written: excellent
  • Verbal: excellent
  • Interpersonal: excellent


Essential Functions - Physical Demands & Working Conditions
  • PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
  • Regularly required to operate standard office equipment (computer, copy/fax machine, etc.)
  • Ability to work on a computer up to 7 hours a day and occasionally sit or stand or walk for long periods of time
  • Ability to work in a dynamic environment which can include but not limited to office, laboratories, manufacturing, off-site venues, etc. depending on functional role.
  • Standard office environment. Potential interaction with laboratory environment with exposure to chemicals.
  • Close vision required for computer usage.
  • Occasionally required to stoop, kneel, climb and lift up to 30 pounds.
  • Required to consistently and properly use Personal Protective Equipment in keeping with Ipsen safety policies and practices.


Environmental, Health & Safety Requirements
  • Comply with all corporate and facility Environmental, Health and Safety policies and procedures. Attend all mandatory EH&S meetings and complete all EH&S training requirements.
  • Intervene in potentially unsafe situations and report any incident, unsafe acts, conditions or equipment. Report any emergency situation (medical emergency/chemical spill/security concern) by following established emergency programs and procedures.


The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

Ipsen Bioscience, 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, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.

Ipsen Bioscience, 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.

All Employees are expected to adhere to all company policies and act as a role model for company values.

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.