Analytical Scientist

Location
Cambridge, MA, United States
Posted
Aug 07, 2018
Ref
477839
Hotbed
Genetown
Required Education
Masters Degree/MBA
Position Type
Full time
Title:
Analytical Scientist

Company:
Ipsen Bioscience, Inc.

Job Description:

Position Summary

Under the direction of the Senior Manager of Analytical Science and Technology, the Analytical Scientist will contribute to the development and optimization of analytical test methods, and analysis of samples as needed to support characterization and release of drug substances (small molecule) and liposomal drug products. The successful candidate will also qualify, validate, and transfer test methods for a commercially-approved drug for treatment of Pancreatic Cancer.

Essential Functions
  • Develop/optimize, qualify and validate new and existing analytical test methods for characterization and release of nano-liposomal drug products, APIs, raw materials, and excipients in GMP and non-GMP environments
  • Perform characterization of impurities and degradation products in drug substance, drug product, and raw materials, including forced degradation and extractable and leachable studies
  • Support development, characterization, and verification of nano-liposomal pharmaceutical products and processes
  • Troubleshoot and maintain equipment, and participate in instrument qualification
  • Author and review technical documents, such as operating procedures, protocols and reports, CAPAs, and Change Controls
  • Serve as subject matter expert in technical meetings and in cross-functional project meetings with other departments within Ipsen and its partner firms
  • Support Quality, Manufacturing, and Process Development investigations
  • Manage external projects at CROs and CMOs, including development, validation and transfer of analytical test methods
  • Partner with Quality Control to evaluate robustness of the analytical method portfolio throughout the method lifecycle, as well as ensure proper training of QC staff and smooth transfer of methods into QC


Qualifications

Education & Certifications
  • Master's degree in chemistry or relevant scientific discipline with 4+ years of experience in analytical development or QC chemistry; or Bachelor's degree in chemistry or relevant scientific discipline with 7-10 years of experience.

Experience
  • 5-7 years of recent professional experience in the development, qualification, and validation of analytical methodologies, such as HPLC, GC, CAD, ELSD, IR, and wet chemistry techniques for proteins, lipids, and/or small molecules
  • Track record of independent design and execution of laboratory studies for pharmaceutical products and processes and assisting in complex investigations
  • Familiarity with general requirements and tests from compendia, such as USP, Ph. Eur., and JP, as well as familiarity with industry guidance and regulations, such as ICH, PDA, and 21 CFR 211
  • Excellent organizational skills with well-developed interpersonal, verbal and written communication skills
  • Proficiency with Microsoft tools and discipline-appropriate software (chromatography, statistical, etc.)
  • Experience with mass spectrometry and lipid-based parenteral formulations are both highly desirable
  • Experience with GMP quality systems and working knowledge of cGMP guidelines from FDA, EMA, EDQM, and ICH is highly desirable


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


Other
  • Ability to work weekends pending business needs


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.