As a trusted staffing and recruitment partner, we are committed to connecting you with the perfect opportunity at a global leader in biotechnology. Leveraging our extensive network, we provide access to top-tier roles that allow you to grow and make a meaningful impact in the healthcare and life sciences industries. This company is dedicated to discovering and developing innovative therapies that address serious diseases, with a focus on oncology, cardiology, and bone health. With a strong legacy of scientific excellence and a mission to improve patient outcomes worldwide, they offer a dynamic environment where your contributions will drive real change. If you're seeking a rewarding career that makes a difference, let us help you take the next step!
location: Cambridge, Massachusetts
job type: Contract
salary: $42.00 - 49.20 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
Our Commercial Attribute Sciences department is responsible for commercial analytical support, including method validation, method transfer, method remediation, method investigation support, process and product development as well as manufacturing and QC support.
The Senior Scientist will work closely with a team of analytical & bioanalytical chemists, organic chemists, engineers and formulators responsible for the technical aspects of developing the analytical tools to gain understanding of key attributes for manufacturing processes and products. The Scientist will integrate and successfully utilize platform and prior product knowledge to advance Company practices and ensure success of the commercial and clinical portfolio.
- Strong understanding of analytical methods with an emphasis on small molecules
- Experience in a wide variety of analytical techniques, including mass spectrometry, UV, NMR, FTIR, chromatography, particle size determination, crystal characterization, potency, etc.
- Developing and implementing methods for in-process testing, release and stability testing.
- Familiarity with analytical testing requirements for immediate release and controlled release oral solid dosage drug products.
- Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, etc.
- Solid understanding of GLP and GMP requirements and their application in a phase appropriate manner
- Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, able to manage deliverables against timelines
- Solid communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile
- Working well in cross-functional teams, and across various geographic locations in different time zones
- Excellent technical writing skills and attention to detail in data review, authoring methods, specifications, technical reports and regulatory filing documents
qualifications:
- 0+ Years w/ Relevant PhD, PharmD, MD, or equivalent (and relevant post-doc where applicable) 3+ Years w/ Relevant MS or equivalent 5+ Years w/ Relevant BS or equivalent. Advanced and proficient understanding and use of technical principles, theories, and concepts to perform an expansive range of work in a role. Basic knowledge of related and adjacent disciplinary areas.
- Define analytical control strategies and implement methodologies for late stage programs.
- Collaborate closely with drug substance and drug product Process Development and Quality colleagues.
- Collaborate with cross functional teams to facilitate activities at manufacturing and testing sites (contract and internal).
- Flexibility to commute onsite when needed, a lot of this role will be able to support investigations that pop up and don't know when that will happen - sometimes could be weeks/months no support needed in the lab but then could flip over to 3 months onsite in the lab. No need to be onsite every day - flex role.
- Direct experience in small molecule synthetics lab techniques (wet skills; hplc, uplc, gc - typical types of instrumentation in this skillset) plus additional as is Sr Scientist role so NMR, solid state, etc.
- Strong oral and written communication skills specifically around data analysis - looking at data, analyzing, taking out trends and being able to report back to the manager
skills: CMC, HPLC, ICH Regulations, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
