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Job Details

QC Assistant

Salary
Commensurate With Experience

Location
Cambridge, MA

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Job Description
Company Profile:
Ipsen is a dynamic and growing global specialty-driven biopharmaceutical
company,
focused on innovation and specialty care. At Ipsen, we’ve created a workplace that recognizes and promotes an entrepreneurial spirit in our employees, and are building a strong legacy of helping patients with difficult-to-treat diseases across oncology, neurosciences and rare diseases. We know we can only be better and smarter if we work diligently together as ONE Ipsen, across all functions and geographies. We strive to break down silos and empower teams to deliver effective therapeutic solutions through highly differentiated medicines for patients with unmet needs.
We take pride in our culture, which is rooted in collaboration, to deliver results for our core customer – the patient. This level of involvement by cross-functional teams promotes a strong sense of
unity,
and pulls together all colleagues locally and across our key geographies, which span 115 countries across North America, Europe
and
Asia. As a growing organization, Ipsen North America is comprised of our United States and Canada locations, with employees supporting functions including Commercial Operations, R&D, Business Development and Technical Operations.
Our employees are the driving force behind our mission at Ipsen, and to sustain their passion and focus every day, we offer a wealth of fulfilling challenges and growth opportunities through unique leadership and training programs. At Ipsen, you will work alongside industry leaders and contribute within a fast-moving and truly game-changing global organization, recognized for its talent and patient solutions. At Ipsen, we’re making hope a reality for the patients we serve.
Summary:
We are seeking a talented Quality Control Assistant/Associate to join our team in Cambridge! Your primary responsibility will be to support release and stability testing for a commercially approved drug for treatment of Pancreatic cancer. Additionally, you will participate in investigations and troubleshooting of aberrant data and equipment issues.
Responsibilities:
Perform product and act as a lead in the development, optimization, qualification and/or validation of analytical methods used for the analysis of protein and liposomal drugs
Mentor junior analysts on assay performance
Identify and assist in Troubleshooting aberrant data, maintain validated equipment and perform multiple HPLC based and wet chemistry analytical methods
Assist with guidance on investigations for Quality Instances, CAPAs, and Change Controls
Participate in OOS/OOT investigations and work cross-functionally with quality assurance, process development, manufacturing, and research and development
Present data in team meetings and act as a lead on multiple projects within the QC lab
Skills/Requirements
Education
BA/BS degree in Biochemistry (or a related field)
Experience
1-2 years of recent professional experience in a QC lab
Background in performing HPLC based assays for proteins, lipids, and/or small molecules under cGMP
Demonstrated experience in GMP quality systems
Some Knowledge 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
Strong organizational 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
Other
Ability to work weekends pending business needs
Essential Functions – Physical Position Requirements: Machines and/or Equipment Used
PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
Regularly required to operate standard office equipment (personal computer, photocopy machine, fax machine, etc.)
Ability to work on a computer up to 7 hours a day.
Regularly required to sit for long periods of time, and occasionally stand and walk.
Regularly required to use hands to operate
computer
and other office equipment.
Close vision required for computer usage.
Occasionally required to stoop, kneel, climb and lift up to 25 pounds.
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

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