Job Title - Senior Scientist
Duration - 12+ Months
Location - Cambridge, MA 02138
Work Schedule - 2-3 days onsite weekly

Ideal Candidate:

• B.S. and 6+ years of experience
• Analytical techniques for small molecules

Job Details:
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 ** practices and ensure success of the commercial and clinical portfolio.

Basic 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

Top 3 Must Have Skill Sets:

• 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)

Day to Day Responsibilities:

• 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

Interview Process:

• Possibly 2 rounds, 1 with the hiring manager and second with teammates.

 

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
 
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
 
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
 
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer. 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $43.00/hr.