Jobs in Lexington, MA

Position: Associate Director, Clinical Quality Compliance

Location: Bedford, MA (On-site 3 days/week)

Length: 6 Month Contract

Please no agencies. Direct employees currently authorized to work in the United States – no sponsorship available.

Job Description:

The Associate Director, Clinical Quality Compliance will be a primary quality contact for GCP and GCLP compliance. This person will support the clinical study teams towards ensuring compliance with global regulations (e.g., FDA, EMA, etc.) and will be required to contribute to developing the right strategies for the design and execution of all clinical and bioanalytical studies. This person will be responsible for establishing our clients inspections management program for GCP inspections and expected to be influential towards maturing the quality culture and help reach a sustained state of inspection readiness. This person will contribute to and execute the Clinical Quality Management Plan for compliance and risk monitoring for all the clinical studies. This person is required to contribute to establishing a scalable Quality Management System that is always ready for inspection. This role requires the person to identify and effectively communicate compliance risks and assist with developing sound strategies and drive action plans to mitigate risks.

Essential Duties and Responsibilities:

• Contribute to the development and maintenance of procedures for the GCP/ GCLP managed activities.
• Partner closely with members of the Clinical Development team to support the successful and compliant execution of clinical studies to meet regulatory requirements, guidelines, internal policies, and procedures.
• Develop and maintain integrated data-driven risk-based quality management plans to monitor the health of compliance.
• Participate in the development of GCP/GLP auditing strategies.
• Support investigations into scientific misconduct and/or serious breach of GCP. Partner with CROs and the clinical study team to analyze investigation findings to identify root/probable cause. Ensure adequate investigation, documentation, and implementation of appropriate CAPAs. Assure timely reporting of potential or confirmed violations, as appropriate, to regulatory agencies.
• Provide GCP compliance interpretation, consultation, training, and other supportive services necessary to maintain and improve the quality of research for timely regulatory submissions.
• Establish the GCP inspection preparation program and facilitate mock PAI inspections as necessary.

Qualifications:

• BS/BA, MS or PhD and a minimum of 10 years’ experience, respectively, in Biotech, Pharma or CRO.
• Working knowledge of relevant FDA, EU, ICH GCP / GCLP regulations and guidelines.
• Proficient auditing skills with the ability to identify risks based on objective evidence and communicate findings in a sound and factual manner.
• Ability to work autonomously, effectively manage time and deliver results on time.
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
• Conflict resolution/management and negotiation skills.
• Ability to manage multiple projects in a fast-paced environment.
• Excellent organizational, interpersonal, verbal, and written communication skills.

POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.

Come see why DPC has achieved:

• 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 ‘Employee’s Choice - Best Places to Work’ by Glassdoor.
• Voted ‘Best Staffing Firm to Temp/Contract For’ seven times by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.

As you are applying, please join us in fostering diversity, equity, and inclusion by completing the Invitation to Self-Identify form today!

# 18352

*2nd shift, 3-11pm*

Job Summary

The Manufacturing Supervisor provides hands-on leadership of second shift GMP manufacturing operations for microbiome Live Biologic Products. This role supervises four contract associates and ensures safe, compliant, and efficient execution of fermentation, harvest, lyophilization, media/buffer preparation, packaging, and suite readiness activities. The Supervisor serves as the primary on-site manufacturing leader during second shift and actively supports floor operations.

Responsibilities

• Supervise second shift GMP manufacturing activities, including fermentation and downstream processing.
• Lead and support four contract manufacturing associates; assign tasks and provide coaching.
• Ensure production suites, equipment, and materials are ready and compliant.
• Enforce cGMP, safety, and quality standards.
• Review batch records and documentation for accuracy and completeness.
• Execute shift schedules to meet production timelines.
• Escalate and support resolution of manufacturing issues, deviations, CAPAs, and change controls.
• Support new processes, SOP implementation, and technology transfers.
• Provide clear shift handovers and communicate production status and risks.

Qualifications

• Bachelor’s degree in Biology, Biochemistry, Engineering, or related field preferred.
• 3–6 years of GMP manufacturing experience; prior supervisory or lead experience preferred.
• Experience with fermentation, microbial processing, aseptic techniques, or lyophilization preferred.
• Strong knowledge of cGMP regulations and documentation practices.
• Experience reviewing batch records and supporting deviation management.

Position Summary:

The Associate Director, Quality Control will be responsible for providing strategic, scientific, and operational leadership for the development, qualification, validation, and lifecycle management of analytical methods supporting Upstream Bio’s lead program verekitug. This role will manage and execute GMP quality control (QC) activities directly related to batch release for clinical trial material supply. The leader in this role must assure that quality controls for investigational new drugs (investigational medicinal products) meet all quality requirements, regulatory standards, and meet continuous clinical supply and delivery expectations. The Associate Director will report to Senior Director of Analytical and serve as a key partner to Quality, CMC, Regulatory, and cross-functional teams. This individual will provide technical guidance and business acumen to ensure execution of analytical activities for late-stage programs through BLA/MAA submission, approval, and commercial launch.

Key Responsibilities:

• Author, review and approve analytical method procedures/SOPs
• Author, review and approve analytical method transfer/qualification/validation protocols and reports
• Manage external CDMOs and CROs to execute Development and GMP release and stability testing of Drug Substance and Drug Product in a compliant-manner
• Establish and manage reference standard and critical reagent programs
• Participate in the laboratory quality system activities such as internal audits, writing standard operating procedures, and documentation review.
• Perform data verification and audits in order to ensure accuracy of data and analytical processes.
• Ensure compliance with company policies and SOPs as well as global health authority guidelines.
• Create, analyze, verify, and approve QC data such as method validation, release and stability, results, reports, and Certificates of Analysis (COAs).
• Generate, review, and revise specifications, SOPs, and other QC laboratory and testing documentation.
• Lead Out-of-Specification (OOS), Out-of-Trend (OOT), and Deviation investigations related to the QC laboratory and ensure effective corrective and preventive actions (CAPAs) are implemented.

Qualifications:

• Experience in stability study performance/evaluation and/or knowledge/familiarity with USP/compendial testing is helpful.
• Excellent verbal and written communication/interpersonal skills, problem-solving skills, organizational skills, and the ability to work in a diverse team environment are essential.
• Proficiency with Microsoft software (Word / EXCEL / PowerPoint), Stability software and statistical analysis/trending to support shelf life and labeling is expected.

Knowledge and skills (general and technical) preferred:

• Broad background, strong comprehension, and demonstrated skills in analytical methods development/validation/transfer/similar, reference standards characterization/structural elucidation, and unknown identification.

Education level and/or relevant experience required:

• Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 10+ years of demonstrated success in leading cross-functional teams and managing projects along with 7+ years relevant analytical experience in a cGMP-compliant pharmaceutical laboratory environment. Any ASQ or other certifications is a plus.

About Upstream Bio:

Upstream Bio is a public company based in Waltham, MA. We are developing verekitug, the only known antagonist currently in development that targets the receptor for Thymic Stromal Lymphopoietin (TSLP). We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) and plan to initiate development in chronic obstructive pulmonary disease (COPD). Our experienced team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. Learn more about us at .

Compensation

Target Salary Range: $176,400 - $215,600

*Base Compensation for this role will depend on a number of factors including a candidate’s qualifications, skills, competencies, and experience. Base pay is only one component of the company’s total rewards package. All regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.

Sr. Quality Control & Sample Management Specialist

Our client is looking for an experienced QC and sample management professional to support high‑quality data generation within our Translational DMPK and Clinical Pharmacology team. This role ensures accuracy, compliance, and smooth sample lifecycle management across internal and external studies.

Responsibilities

• QC review of bioanalytical data (LC‑MS/MS, ELISA, qPCR) and study documentation from internal teams and CROs
• Manage and review scientific documents in SharePoint
• Format internal reports and provide templates to CROs
• QC review of packing slips, manifests, and critical reagent documentation
• Contribute to drafting and editing bioanalytical lab guidelines
• Routine QC of Electronic Lab Notebooks
• Audit finalized reports and maintain errata
• Use LIMS (LabVantage) for sample receipt, tracking, aliquoting, storage, shipping, and disposal

Requirements

• Bachelor’s degree in a scientific or healthcare field
• 5+ years QC experience in pharma, biotech, or CRO environments
• Proficiency with LIMS (LabVantage preferred) and electronic notebooks
• Strong understanding of GxP regulations
• Excellent attention to detail, communication, and organizational skills
• Proficiency in Microsoft Word, Excel, and PowerPoint
• Familiarity with bioanalytical assays is a plus

Medical Device Manufacturing Engineer Co-Op/Intern

On-site in Seaport, Massachusetts May-August (extension possible)

Amplitude Vascular Systems (AVS), an early-stage medical device company focused on safely and effectively treating severely calcified arterial disease, is seeking a Manufacturing Engineer-Co-Op to support our Operations team. This individual will work in a cross-functional role (Quality/Manufacturing/R&D) supporting the manufacturing of devices and associated instruments and technologies.

Key Responsibilities:

• Willing to work for cross functional teams (Operations, R&D and Quality & Regulatory.)
• Creating and modifying designs/drawings utilizing SolidWorks
• Testing prototype devices for functionality
• Supporting manufacturing with failure analysis
• Working in the lab, summarizing data, performing tests, and writing technical reports
• Participating and collaborating in team meetings and updates.
• Experience in Microsoft Word, Excel, and PowerPoint is essential
• Ability to work independently as well as take direction and complete tasks with or without help or supervision.

.Qualifications:

• In pursuit of Bachelor's degree in Mechanical, Industrial, Manufacturing, Electrical, or Biomedical Engineering. In Junior year or above.
• Self-motivated with an interest in medical devices
• 3-D modeling skills (NX Unigraphics & Solidworks Preferred)
• Experience using hand tools and performing mechanical testing
• Proven problem-solving capabilities
• Ability to communicate technical information
• Previous co-op completed in manufacturing at a medical device demonstrating skillsets listed above preferred.
• A minimum G.P.A. of 3.0
• Available to work full-time (40 hrs/week) May-August 2026
• This is an onsite position located in Waltham, MA.

AVS is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Join a leading pharmaceutical company’s Data Science team, where you’ll drive and lead advanced analytics across Marketing, Sales, and Access. As Associate Director (Or Sr Manager), A HIGH LEVEL INDIVIDUAL CONTRIBUTOR, you’ll lead strategic initiatives from predictive modeling and personalization to field force optimization, delivering scalable solutions that inform commercial decisions and enhance patient engagement. Deep experience in pharmaceutical marketing analytics is essential to translate brand strategy into actionable insights.

Keywords: MMM, Next Best Action, NLP, Data Science, HCP, GenAI

Location: Onsite 3 days a week in Cambridge, MA

Key Responsibilities

• Lead development and deployment of predictive models, segmentation, NLP, and GenAI tools to solve complex commercial challenges
• Translate pharmaceutical brand objectives into analytics frameworks across marketing, sales, and access
• Design and operationalize Next Best Action strategies to boost omnichannel engagement and HCP ROI
• Build and scale Patient 360 models and targeting algorithms for AI-driven lead generation
• Guide stakeholders through insight activation and integration into workflows
• Champion model governance, experimentation, and analytical rigor
• Collaborate with IT to develop ML Ops environments and productized solutions
• Manage external analytics partners and ensure alignment across data engineering, insights, and compliance

Who You Are

A strategic data scientist with strong business acumen, leadership presence, and deep experience in pharmaceutical marketing analytics. You thrive at the intersection of data and action, delivering measurable impact.

Qualifications

• 5+ years in analytics role within pharmaceutical industry
• Proven experience in pharmaceutical marketing analytics, including brand strategy, HCP engagement, and omnichannel optimization
• Expertise in NBA, MMM, supervised/unsupervised learning, A/B testing, time-series forecasting
• Success in marketing mix modeling, decision engines, and GenAI product design
• Proficient in Python, R, SQL, Snowflake; skilled in Power BI or Tableau
• Familiarity with APLD, PlanTrak, claims, and specialty pharmacy datasets
• Strong communicator with executive presence and cross-functional influence

Send resume to

About Goodpath

Goodpath delivers integrative, AI-powered care for chronic conditions - blending 22 medical

disciplines into one personalized experience. We partner with employers, payors, and platforms

to reach members with industry-leading engagement and outcomes. We doubled ARR last year

and recently closed an $18M Series A to accelerate our next phase of growth.

The Role

We’re looking for a Chief of Staff to serve as the CEO’s right hand and keep the company

operating at its best. This is a high-leverage, cross-functional role: you’ll own the operating

rhythm of the company and step into whatever the business needs most – whether that’s

finance, hiring, investor relations, or special projects. The scope will evolve as Goodpath grows,

and so will you.

This is the right role for someone who thrives in ambiguity, moves fast, and takes pride in

making everyone around them more effective. You’ll report directly to CEO Bill Gianoukos.

What You’ll Do

• Own board and investor communications: prepare quarterly board materials, draft monthly investor updates, and manage investor relations
• Drive the company's operating cadence: keep the team aligned through goal-setting, accountability, and cross-functional coordination
• Lead core business functions as needed – this could include finance, operations, hiring, or other areas depending on where priorities lie at any given time
• Drive recruiting and people operations: oversee hiring pipelines, coordinate with hiring managers, and ensure a high-quality candidate experience
• Act as the CEO’s strategic partner: prep for key meetings, manage priorities, and serve as a trusted thought partner across the business
• Build team culture: plan offsites, all-hands meetings, and other touchpoints that keep a remote-first team connected
• Take on high-impact special projects that don’t fit neatly into any one function but are crucial in helping the business move forward

What You Bring to the Table

• 3–5 years of experience in operations, strategy, consulting, venture capital, or a similar high-output generalist role
• Financial fluency: you’re comfortable building financial models, managing a budget, and presenting to a board
• Extreme organizational skills and attention to detail – nothing falls through the cracks on your watch
• Strong written and verbal communication – you can draft an investor update or run a team meeting with confidence
• Comfort with ambiguity and unstructured environments – you don’t need a playbook to be effective
• Tech-savvy and eager to use AI and automation to work faster and smarter
• Healthcare or healthtech experience is a plus, but not required
• (Bonus points if you speak Greek…we have a team based in Greece)

You’ll Be Successful Here If You…

• Are a self-starter who takes ownership and doesn’t wait to be told what to do
• Get energy from wearing many hats and context-switching across finance, ops, people, and strategy in the same day
• Are not afraid to get your hands dirty – no task is beneath you if it moves the company forward
• Communicate with clarity and can distill complexity into action
• Want to build something meaningful at a company helping lead the future of GLP-1s and weight management

Compensation

• Base salary range: $100,000–$130,000 (dependent on experience)
• Meaningful equity in a hyper-growth Series A company
• Medical, dental, and vision insurance
• 401(k)
• Free Goodpath programs for you and your family

Why Join Us

• Join a mission-driven company at a clear inflection point
• Work directly with the CEO as his most trusted partner
• Shape the operating backbone of a rapidly scaling company
• Be part of a humble, high-performing team driven by meaningful impact
• Dynamic environment with room to learn, grow, and shape the company’s future

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess’ patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.

The Role

We are seeking a motivated and detail-oriented Research Associate with strong hands-on experience in chromatographic analysis to support QC release and stability testing. The successful candidate will perform routine cGMP QC testing using HPLC methods (RP-HPLC, SEC, IEX), Agilent HPLC systems, and additional supporting assays in a fast-paced, collaborative environment. This is a unique opportunity to be part of an emerging early-phase clinical company bringing innovative technology to the global market.

Key Responsibilities

• Perform routine QC release and stability testing using HPLC methods including RP-HPLC, SEC, and IEX.
• Prepare samples, operate Agilent HPLC systems, verify system suitability, and ensure analyses meet method and specification requirements.
• Execute complementary analytical assays such as UV-Vis, pH, surface tension, and mechanical tests.
• Maintain complete, accurate documentation in compliance with cGMP, ALCOA+, and data integrity requirements.
• Conduct routine instrument care (solvent flushes, column care, daily checks) and assist troubleshooting under supervision.
• Process and review chromatographic data in Agilent OpenLab CDS.
• Support method qualification, validation, and transfer activities by executing protocols and recording observations.
• Maintain calibration, maintenance, and service records for analytical instrumentation.
• Independently author method SOPs, analytical protocols, technical reports, and contribute to regulatory submissions.
• Collaborate cross-functionally with QC, Analytical Development, Process Development, Manufacturing, and Regulatory teams to enable program success.
• Maintain rigorous laboratory documentation and complete, audit-ready analytical records.
• Thrive in a fast-paced, cross-functional environment with excellent communication and organizational skills.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or related field with 1–3 years of experience; or a master’s degree with relevant laboratory experience.
• Hands-on experience operating HPLC systems; Agilent systems and OpenLab CDS experience strongly preferred.
• Practical experience with chromatographic techniques including RP-HPLC, SEC, and IEX.
• Experience supporting QC release or stability testing in a GMP/GLP environment.
• Strong attention to detail and ability to follow SOPs precisely.
• Excellent documentation practices and understanding of data integrity.
• Strong organizational skills with the ability to manage multiple workflows and prioritize effectively in a fast-paced environment.
• Excellent verbal and written communication skills and comfort working within interdisciplinary teams.
• Commitment to collaborative work within interdisciplinary project teams.

At Vaxess, we’re bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to

Title: Board Certified Behavior Analyst(Hybrid)

Location: Newton, Canton, Quincy, Lowell, MA and Providence, RI - able to choose from 1 location

Hours: 8:30-3:30

Pay: From $90k/year - $95k/year - bonus of $65/hr for any extra billable hours per week.

Environment: Clinic, In home, virtual

Billable Hours: 27/week

Hours per week: 35 hours/week

Job Description:

· The primary function of the Board Certified Behavior Analyst (BCBA) is to plan, develop, and monitor a variety of behavior interventions to meet the needs of clients diagnosed with Autism Spectrum Disorders (ASD) and/or other behavioral and social/communication challenges

· The BCBA also consults with RBT's and other therapeutic team members (i.e., caregivers, Speech Therapists, Physical Therapists, Occupational Therapists, etc.) how to implement behavior analytic strategies; develops and implements comprehensive treatment plans; and monitors progress regularly by analyzing data

· The BCBA manages the child’s ABA Team and provides ongoing training and direct supervision to team members

· Direct supervision for RBTs who deliver direct ABA services to clients

· Use appropriate assessment tools and data to develop and implement individualized behavior analytic treatment plans

· Monitor and modify treatment plans based on direct observations, therapist or parent feedback and objective data collected by therapists or parents

Qualifications:

Must

• Master's Degree in ABA
• Minimum of 1 year as a BCBA

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance
• Free CEUs and professional development