Contract - Quality Assurance Specialist, CMC
2 weeks ago
Title: Contract - Quality Assurance Specialist, CMC
Location: Cambridge, MA and Acton, MA
Reports to: Supervisor, Quality Assurance
About Vedanta Biosciences:
Vedanta Biosciences is a late-stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company's lead assets include potential first-in-class oral therapies, VE303, a Phase 3-ready candidate for recurrent C. difficile infection, and VE202, in a Phase 2 trial for ulcerative colitis. Vedanta's pipeline has been built using the company's industry-leading product engine for the development of therapies based on defined consortia of bacteria grown from pure clonal cell banks. The product engine, supported by foundational IP, includes one of the largest libraries of bacteria isolated from the human microbiome, vast clinical datasets, proprietary capabilities in consortium design, and end-to-end CGMP manufacturing capabilities at commercial launch scale.
The Role:
The QA CMC Specialist is responsible for performing a wide variety of activities to ensure manufacturing compliance with applicable regulatory and CGMP requirements. The primary role is to provide QA support to the set-up, execution, and closure activities and processes related to product manufacture. This includes Master Batch Record changes and approvals, production batch record reviews and disposition activities and initiation and resolution of Quality Systems related to manufacturing (CAPA, Change Control, Deviations). This role requires onsite work Monday through Friday.
Here's What You'll Do:
- Support material manufacturing for clinical phase programs and manufacturing facilities.
- Interface with Manufacturing, Technical Operations, Supply Chain, Facilities, and Quality Control to assist with QA activities.
- Prepare and perform the manufacturing process and Quality Management Systems documentation, such as New Product Introduction, Product Change Over, facility and equipment preparation; coordinate with Manufacturing to conduct QA product changeover walkthroughs of GMP areas, cleanrooms, and room release activities.
- Prepare documentation and records for QA disposition of Vedanta products and clinical trial materials.
- Collaborate with other departments for investigations, risk assessments, EM alerts, change controls, deviations, and CAPAs. Implement Corrective Actions as assigned and assist in investigations.
- Issue manufacturing batch record and logbook, completed records review, and data auditing in support of manufacturing schedules.
- Support on going Quality activities at the Acton and Cambridge facilities.
- Maintain production and Quality records in and support processing in computerized systems (e.g., Veeva Vault)
- Support supplier qualification activities, including review of supplier change notifications and supplier corrective actions.
- Update and maintain QA tracking tools and metrics and documentation.
- Support Internal audits.
Role Complexity and Problem Solving:
In this role, you will:
- Wok on problems of limited scope, with opportunity to expand level of assignments based upon performance.
- Analyze situations or data from which answers can be readily obtained as part of compliance responsibilities, standard practices, and procedures.
- Have your work reviewed periodically based on a set of defined procedures or precedence.
- Receive general instruction on work and new assignments.
Collaboration and Interaction Expectations:
In this role, you will:
- Develop stable working relationships internally.
- Exchange standard/basic information with colleagues, immediate supervisor, project leaders, and other professionals in the team/group.
Requirements:
- Education: Bachelor's degree with minimum of 3 years of related work experience and demonstrated knowledge of scientific principles.
- Experience: 3+ years in GMP CMC operations: manufacturing operations, use and review of manufacturing and supporting documentation. 2+ years experience working in or with Quality Systems, such as manufacturing investigations and risk assessments, change controls, SOP writing/reviewing.
- Overarching knowledge of GMP regulations, drug development process, regulatory product development phases, milestones and key junctures for program development (phase 1/2/3)
- Competency using Microsoft suite (Word, Excel, PowerPoint); familiar with software based quality systems (Veeva, SAP or similar).
- Travel to both Acton and Cambridge facilities required.
- Personal Competencies: self-awareness, integrity, problem analysis, decision making, communication, risk management
- Interpersonal skills: cooperation and collaboration across departments, consensus building, conflict resolution, meeting management
- Written and oral communication; ability to understand complex ideas on manufacturing and technology and develop into actionable tasks and plans and communicate to others.
Vedanta is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vedanta will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Vedanta Biosciences requires all employees to be fully vaccinated against COVID-19 and newly hired employees must be fully vaccinated prior to their employment start date. Vedanta Biosciences will consider accommodations for individuals who are unable to be vaccinated against COVID-19 due to a qualifying medical condition or disability or a sincerely held religious objection.
-
Contracts Manager
2 weeks ago
Cambridge, Massachusetts, United States Sana Biotechnology Full timeAbout the roleSana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who are passionate about delivering the possible to patients, and who lead with the desire to work on novel ideas. In this role, you will support the company's contracting activities. The primary focus of this role is...
-
Specialist, Clinical Quality
6 days ago
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe RoleIn this role, you will function as an internal auditor and will provide clinical quality support related to GCP global regulation and guidelines to Clinical and Research and Development teams. Additionally, the Senior Specialist/Specialist applies established knowledge and experience with GCP regulations, guidelines and local legislation to the...
-
QA Specialist
2 months ago
Cambridge, Massachusetts, United States Proclinical Full timeQA Specialist - Contract - OnsiteProclinical is seeking a QA Specialist - Equipment and Computer Systems to join a global biopharmaceutical company. This is a contract role located in Cambridge, MA.Skills & Requirements:Specialization in Vaccines - Life science - Bioinformatics - Computer Engineering - Regulatory Requirements in Pharmaceutical...
-
Principal Scientist, LNP Development
1 week ago
Cambridge, Massachusetts, United States Beam Therapeutics Full timePosition Overview Beam is seeking a principal scientist with expertise in nanoparticle process and formulation development team. An ideal candidate would have good understanding of late-stage drug product process development. In this role, the individual will work closely with the Discovery, Technical Development, Manufacturing and Analytical groups to...
-
Executive Director, PSC Process Development
5 days ago
Cambridge, Massachusetts, United States Sana Biotechnology Full timeAbout the role Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to translate novel ideas into clinical product. As the Head of Pluripotent Stem Cell (PSC) Process Development, you will report to the Head of Process...
-
Sr. Project Manager, Clinical Supplies
6 days ago
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna is seeking a Clinical Supplies Sr. Project Manager to manage the clinical supplies needs across its projects, as well as, work with packaging and labeling and IRT vendors and CROs. This position works collaboratively across several therapeutic area teams as well as cross functionally to support study needs. This successful candidate will be...
-
Scheduling Coordinator
6 days ago
Cambridge, Massachusetts, United States Allina Health Full timeNumber of Job Openings Available:1Date Posted:February 20, 2024Department: Courage Kenny Rehabilitation Institute Administration Cambridge Medical CenterShift:Day/Evening (United States of America)Shift Length:Variable shift lengthHours Per Week:0Union Contract:L70-3-Cambridge Service and MaintenanceWeekend Rotation: NoneJob Summary:Provides accurate patient...
-
Associate Director, Analytical Development
6 days ago
Cambridge, Massachusetts, United States PepGen Full timeAssociate Director, Analytical DevelopmentPosition Summary Reporting to the Senior Director, Analytical Development & QC, the Associate Director of Analytical Development will be acting as analytical project lead, responsible for supporting the analytical development needs of PepGen's pipeline. In addition, this position will be required to actively support...
-
Cambridge, Massachusetts, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
Digital Marketing Specialist
6 days ago
Cambridge, Massachusetts, United States Randstad USA Full timejob summary: Our client is a well-known private Ivy League research University and Education Leader and they are looking for a Digital Marketing Specialist to join their growing team on a contract through October, with the opportunity for extension. The Digital Marketing Specialist will assist with and coordinate digital marketing and advertising campaigns,...
-
Cambridge, Massachusetts, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading...
-
Contracts Manager
2 weeks ago
Cambridge, Massachusetts, United States Philips Full timeJob TitleContracts Manager (SaaS required - Cambridge, MA)Job DescriptionIn this hybrid role, leverage your expertise in software-as-a-service (SaaS) contract management to develop and negotiate complex enterprise agreements.Your role: Act as the Contract Center of Excellence (CoE) Strategic Partner with Hospital Patient Monitoring (HPM) Sales Team working...
-
Research specialist, Cell Based Assays
2 weeks ago
Cambridge, Massachusetts, United States Proclinical Staffing Full timeResearch Specialist, Cell Based Assays - Contract - Cambridge, Massachusetts Proclinical is seeking a dedicated and innovative Research Specialist on a temporary contract based in Cambridge, Massachusetts.Primary Responsibilities:This role offers the chance to contribute to a growing portfolio of targeted therapies in a dynamic and fast-paced research...
-
Cambridge, Massachusetts, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...
-
Cambridge, Massachusetts, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better...
-
Senior Contracts Analyst
1 week ago
Cambridge, Massachusetts, United States Harvard University Full timeAdditional Information Please provide a cover letter with your application. Please noteHarvard University requires pre-employment reference and background screening. We are unable to provide work authorization and/or visa sponsorship. This position has a 90-day orientation and review period. The health of our workforce is a priority for Harvard University....
-
Sr Manager, Contracts
2 weeks ago
Cambridge, Massachusetts, United States Philips Full timeJob TitleSr Manager, Contracts - Government (Hybrid: Cambridge, MA)Job DescriptionJoin us to improve the health and lives of military veterans, active-duty service members, and other people served by the Federal Government. In this hybrid position, you will lead and support field sales staff by developing account strategies, quoting, and conducting direct...
-
Contracts Manager
2 weeks ago
Cambridge, Massachusetts, United States Philips Full timeJob TitleContracts Manager (Hybrid: Cambridge, MA)Job DescriptionAs an individual contributor, in this hybrid role, you will leverage your experiences in the evaluation, development, and negotiation of commercial transactions, contracts, proposals, and quotes while ensuring compliance with current policies and procedures and minimizing contractual risk.Your...
-
Principal Scientist, Process Development
6 days ago
Cambridge, Massachusetts, United States Cerevel Therapeutics Full timeCompany OverviewCerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Our portfolio of pre-commercial neuroscience assets targets a broad range of central...
-
Contracts Manager
6 days ago
Cambridge, Massachusetts, United States Philips Full timeJob TitleContracts Manager (Hybrid: Cambridge, MA, Nashville, TN or Bothell, WA)Job DescriptionAs an individual contributor, in this hybrid role, you will leverage your contract management skills to partner with sales and customers to evaluate, redline, develop and negotiate commercial transactions, contracts, proposals, and quotes while ensuring compliance...
