Jobs in Waltham, MA

A clinical-stage biotech in the RNAi space is seeking an Associate Director or Senior Manager of CMC to lead external manufacturing activities for a key therapeutic program.

Key Responsibilities

• Manage drug product manufacturing with global CDMOs
• Lead tech transfer, scale-up, and GMP manufacturing campaigns
• Manage batch records, deviations, and quality documentation
• Coordinate analytical testing and stability activities
• Contribute to CMC sections of regulatory submissions

Qualifications

• ~8–10 years of CMC or technical operations experience
• Strong experience managing CDMO manufacturing programs
• Background in GMP manufacturing and tech transfer
• Experience supporting clinical-stage development
• Oligonucleotide experience preferred

Please reach out to for more information.

Company Overview:

Berkshire Grey is a leader in AI-powered robotic solutions that automate fulfillment, supply chain, and logistics operations. Our technology transforms pick, pack, move, and sort operations to deliver unmatched efficiencies to customers in retail, eCommerce, and logistics. At Berkshire Grey, we drive productivity while reducing costs, creating exceptional customer experiences, and enabling better employee engagement.

Position Summary:

We are seeking a highly experienced Senior Manufacturing Engineer with 10+ years of experience in robotic or industrial systems to lead the development, deployment, and continuous improvement of advanced manufacturing processes. The ideal candidate brings deep technical expertise in automation and industrial robotics, along with demonstrated success managing contract manufacturers in complex production environments.

Experience in automotive or aerospace manufacturing environments is highly valued, particularly within structured quality systems and high-reliability production settings.

This role is responsible for driving scalable manufacturing strategies from prototype through full production, ensuring operational excellence across internal operations and external manufacturing partners.

Key Responsibilities:

• Lead the development, implementation, and optimization of manufacturing processes for robotic and automated systems.
• Serve as the primary technical interface between engineering and contract manufacturers (CMs).
• Own technical engagement with contract manufacturers (CMs), driving process readiness, production ramp, cost control, and quality performance.
• Lead product transfers from engineering to full-rate production, including external manufacturing partners.
• Establish and enforce robust manufacturing documentation packages (BOMs, work instructions, control plans, test procedures, tooling specifications).
• Drive DFM/DFA reviews to ensure products are optimized for scalable, cost-effective manufacturing.
• Lead manufacturing validation activities, including pilot builds, process capability studies, and PPAP (as applicable).
• Provide on-site support at CM facilities to resolve escalated production and quality issues.
• Lead structured root cause analysis and corrective action efforts (8D, A3, RCCA) across internal and external operations.
• Specify and implement tooling, fixtures, and automation solutions to improve repeatability and throughput.
• Drive continuous improvement initiatives focused on safety, quality, delivery, and cost.
• Ensure compliance with applicable industry quality standards and regulatory requirements.
• Mentor junior manufacturing engineers and technicians as needed.
• Frequent visits to our contract manufacturer in West Boyleston, MA
• Potential of occasional travel to other CMs and/or supplier sites

Required Qualifications:

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related field.
• 10+ years of manufacturing engineering experience in robotic, automation, automotive, aerospace, or industrial equipment environments.
• Significant experience working with and managing contract manufacturers, including new product introduction (NPI), production ramp, and sustaining operations.
• Proven experience transferring products from development to high-volume or high-reliability production.
• Hands-on experience with industrial robots (e.g., FANUC, ABB, KUKA, Yaskawa) and automated systems integration.
• Strong working knowledge of manufacturing processes including mechanical assembly, fabrication, machining, and system integration.
• Experience troubleshooting PLC-controlled systems and industrial controls.
• Experience operating within automotive (IATF 16949) or aerospace (AS9100) environments or equivalent structured quality systems.
• Proficiency in CAD tools and strong ability to interpret engineering drawings and GD&T.
• Demonstrated use of structured problem-solving methodologies (8D, A3, Six Sigma).

Preferred Qualifications:

• Experience with APQP, PPAP, FMEA, control plans, and formal production validation processes.
• Experience qualifying and auditing contract manufacturers.
• Experience in high-mix/low-volume or configurable industrial systems.
• Lean manufacturing and/or Six Sigma certification.
• Familiarity with ERP/MRP systems.
• Experience engaging and managing a Contract Manufacturer; new product introduction through full scale production.

Key Competencies:

• Strong technical leadership and ownership mindset.
• Ability to drive accountability with contract manufacturers while maintaining collaborative relationships.
• Ability to influence cross-functional teams and external partners.
• Systems-level thinking with focus on quality, reliability, and scalability.
• Strong communication and stakeholder management skills.
• Results-driven with a bias toward action and accountability.
• Bias toward action and continuous improvement mindset.
• Comfortable operating in a fast-paced, evolving manufacturing environment.

We Value:

• Experience in warehouse automation, robotics, or large-scale industrial systems.
• Familiarity with ISO 9001 or similar quality management frameworks.
• Experience scaling quality processes in a growing or fast-paced organization.
• Background in reliability engineering, field quality, or lifecycle quality management.

Why Berkshire Grey?

• Opportunity to work with cutting-edge AI-powered robotic solutions that are transforming the supply chain and logistics industry.
• A culture of innovation and collaboration, with a commitment to professional development and growth.
• Competitive compensation and comprehensive benefits package.

I acknowledge that Berkshire Grey is an Equal Opportunity Employer, and Berkshire Grey prohibits discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, and any other protected characteristic as outlined by state, federal or local laws.

I also acknowledge I have been informed that 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.

Overview

A leading biotechnology organisation is seeking an experienced Executive Director, Clinical Quality Assurance to provide strategic leadership across clinical quality operations. This role is responsible for ensuring compliance with global regulatory standards (GCP, GVP, GLP) while driving continuous improvement in clinical quality practices.

Working closely with senior leaders across Quality, Discovery, and Development, you will shape and execute global and regional quality strategies aligned with pipeline objectives. This position plays a critical role in setting the vision, standards, and long-term direction of the Clinical Quality Assurance function.

Responsibilities

• Lead the development and execution of clinical quality assurance strategies, ensuring compliance with global regulations and industry standards
• Establish and maintain robust quality systems, including SOPs, policies, and quality documentation
• Drive continuous improvement initiatives to enhance quality, efficiency, and compliance across clinical operations
• Develop and implement risk management frameworks to identify, assess, and mitigate clinical risks
• Define and monitor key quality metrics and KPIs, providing regular updates to senior leadership
• Collaborate cross-functionally with clinical operations, regulatory, pharmacovigilance, and other teams to ensure alignment
• Build and lead a high-performing Clinical Quality Assurance team to support the clinical development portfolio
• Oversee vendor qualification, audit programmes, and ongoing compliance for external partners (e.g., laboratories, CMOs, depots)
• Develop and manage audit strategies for clinical sites and vendors
• Lead preparation and management of regulatory inspections, acting as the primary point of contact for health authorities
• Support training, inspection readiness, and remediation activities as required
• Promote a strong culture of quality and compliance across the organisation

Requirements

• Bachelor’s degree in a scientific discipline (advanced degree preferred)
• +10 years experience in GCP Quality roles
• Proven experience in both strategic and operational clinical quality assurance
• Strong understanding of GCP, GLP, GVP, and broader GxP requirements
• In-depth knowledge of regulatory requirements across multiple regions (e.g., US and EU)
• Excellent communication and stakeholder management skills

*This is a field sales position that requires you to be located and frequently travel to customers sites within the Massachusetts territory.

SUMMARY OF POSITION

Howard Technology Solutions is a rapidly expanding technology solutions provider for the Healthcare, K-12, Higher Education, Government and Commercial markets. HTS is looking for a highly motivated Account Executive to join our team.

The Higher Education Account Executive is responsible for the promotion and sale of technology solutions to Higher Education facilities within a designated territory. In addition to a strong background in technology, this individual will work with customers to determine their business requirements, create solutions and ensure a smooth sales process. This is a “results oriented” position that requires an organized, hardworking, self-driven, and focused individual determined to meet sales quotas.

PRIMARY RESPONSIBILITIES

• Developing relationships with Technology Coordinators, CIOs, Network Administrators and Audio Visual Directors.
• Achieve territory sales quota
• Actively and consistently prospect and develop new business
• Build customer relationships
• Conduct presentations and in-service trainings
• Monthly forecasting
• Plan personal work schedules, prioritizing work tasks and responsibilities
• Complete weekly Sales Productivity Reports
• Daily updates of CRM system

PHYSICAL REQUIREMENTS

• Position requires Account Executive to be located in the specific territory
• Requires willingness to work a flexible schedule (occasional weekend and/or evening work)
• Requires extensive travel within the territory, including overnight travel within the territory

SKILLS/QUALIFICATIONS

• Four-year college degree from an accredited institution is preferred but not mandatory
• Must be able to develop relationships
• Strong desire to be in the technology sales segment
• Corporate level proficiency in MS Word, Excel, PowerPoint, official e-mailing, and computer skills, etc.
• Presentable, courteous and pleasant personality
• Exhibit a sense of urgency
• Hardworking, sincere, honest, dedicated and self-achiever
• Excellent verbal and written communication skills are required

COMPENSATION

• Base Pay + Commission

BENEFITS

• Medical Insurance
• Dental Insurance
• Disability Insurance
• Life Insurance
• 401K Retirement
• Education Reimbursement
• Paid Holidays
• Paid Vacations

Equal Opportunity Employer Vet/Disabled

About the Company

Our client is a rapidly growing FinTech SaaS provider delivering innovative accounting application software solutions that help enterprise businesses optimize financial operations, compliance, and decision-making. With a strong presence across North America and Europe, they’re known for their high-performing technology, customer-first culture, and impressive client retention rates.

Compensation & Benefits

• $145,000 base salary + $50,000 variable (OTE $195,000)
• Remote working (Boston HQ)
• Health, dental, and vision insurance
• 401(k) match
• Generous PTO and career development opportunities

The Opportunity

We’re seeking an accomplished strategic Key Account Manager to oversee a portfolio of 10 enterprise customers with a combined book of business worth $6–9 million USD ARR.

This is a strategic, relationship-led role focused on driving customer growth and satisfaction through upselling, cross-selling, and proactive account management. You’ll work closely with senior stakeholders (CFOs, CIOs, Finance and Operations leaders) to identify new opportunities, ensure solution adoption, and deliver measurable business value.

Key Responsibilities

• Manage and grow a portfolio of 10 high-value enterprise clients, including major banks, ensuring long-term success and revenue retention.
• Develop and execute tailored account growth plans to expand solution adoption and identify upsell / cross-sell opportunities.
• Maintain strong, trusted relationships with C-level and senior business leaders within client organizations.
• Act as the primary point of contact, coordinating cross-functional teams (Customer Success, Product, and Solutions Consulting) to deliver seamless client experiences.
• Monitor account health, renewal cycles, and satisfaction metrics to ensure high retention and continuous engagement.
• Negotiate renewals and expansions, achieving and exceeding individual and team revenue targets.
• Stay current on FinTech trends, compliance requirements, and SaaS best practices to position the company as a strategic partner.

About You

• 5+ years of experience in Key Account Management or Customer Success within FinTech, SaaS, or enterprise software.
• Proven record of managing and expanding enterprise accounts worth $8M+ ARR.
• Strong commercial acumen and experience with renewals, upsells, and cross-sells in complex B2B environments.
• Confident in engaging and influencing C-suite executives and senior decision-makers.
• Exceptional relationship-building, negotiation, and communication skills.

Salary Range: $90,000k- $115,000 (depending on experience)

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.

Research & development at Vaxess is cross-disciplinary, integrating mechanical, industrial, biomedical, and chemical engineering with chemistry, biology, and human factors to address important unmet medical needs. We are seeking a talented, collaborative, and highly motivated engineer to join our growing team. This role offers a unique opportunity to build manufacturing capacity from the ground up to bring innovative technology to the global vaccine and therapeutic market.

Responsibilities:

• Characterize and improve manufacturing process unit operations by designing, executing, and analyzing process development experiments; communicate results via written reports and oral presentations to internal and project teams
• Support manufacturing scale-up by assessing novel equipment, work flows, analytical techniques/PAT, and process configurations
• Support manufacturing operations by incorporating equipment and process improvements within established processes and equipment trains, and by revising manufacturing batch records, SOPs, and other controlled documents to reflect changes; contribute to implementing and maintaining Vaxess’ Quality System.
• Supervise and mentor junior engineer(s) and technicians, including a direct report
• Collaborate closely with cross-functional teams to support product development and manufacturing activities

Qualifications:

• BS in Mechanical Engineering, Biomedical Engineering, or a related discipline
• 2 – 7 years of relevant direct R&D experience within the medical device or biopharmaceutical industries; experience working on combination products is highly desirable
• Demonstrated success using empirical and first-principles models to inform and analyze experiments; experience with statistical methodologies and working with large data sets (e.g. Six Sigma, DoEs, multivariate techniques) is a plus
• Excellent time and project management skills and proven ability to meet goals and deadlines
• Demonstrated abilities to learn new skills and fields, creatively solve challenging technical problems, think independently, and work collaboratively in diverse multidisciplinary teams
• Entrepreneurial spirit and drive to positively impact global human health

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

Job Title: Nurse Manager (Endoscopy)

Location : Concord, MA 01742

Shift : 5x8 hour Days 40 hours/week

Contract: 13 +weeks

Start Date: 03/30/2026

Weekly Gross: $4,410

$1,610 is a stipend (nontaxable)

$2,800 is taxable

Local pay ranges: ($95 - $97)/hr.

Strong assistant manager can be accepted with approval**.

NOTE**:- Endoscopy RN's welcome to apply and are accepted at different rate

Experience:

• Minimum of 5 years of nursing experience within specialty area and 3-5 years of supervisory experience preferred.
• An equivalent combination of education and experience which provides proficiency in the areas of responsibility listed above may be substituted for the above education and experience requirements
• Licensure and/or Certification: Current RN license in the state of Massachusetts.

If interested or know someone, reach out directly to my recruiter:

Nitin Gupta (Pacer Staffing LLC)

Email:

Ph. 445-201-1029

Immediate need for a talented Bioinformatics Research Associate II . This is a 12+months contract opportunity with long-term potential and is located in Waltham, MA (Onsite). Please review the job description below and contact me ASAP if you are interested.

Job ID:26-08726

Pay Range: $40 - $50/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Manager Notes:
• DIL: bio to support next-gen sequencing group. Some are in the lab, some are writing codes and analytical pipelines, working with Client coding and development systems, collaborating with the lab team, lots of coding, working with quality teams to ensure meeting metrics.
• Should have experience with at least one or two of the following. e.g., FastQC, Bowtie2, SAMtools, NCBI BLAST+, Nextflow, etc.). NGS pipeline development.
• 9-5 some wiggle room if they need to come in earlier leave earlier, Onsite but if they need a day or two here and there they can request a day to work remote A strong candidate would have Coding experience, papers published on coding, need next gen sequencing analysis, gene therapy group so if they have some exp in that or bio that would be a great advantage.
• Relevant experience is more important than a degree for the role.
• Does not want to see anyone with zero coding experience. No mention of the tools list would be a hard pass.
• Support computational needs for the development and validation of NGS-based assays.
• Work closely with a multi-disciplinary team of scientists and engineers to implement genomic analytical solutions for programs spanning precandidate selection through late phase clinical development.
• Develop, execute, and maintain NGS analysis pipelines for execution in cloud-based computational environments.
• Keep records of development work and testing in a GxP environment utilizing electronic notebook solutions.
• Represent the group at internal meetings.

Key Requirements and Technology Experience:

• Key Skills;Should have experience with at least one or two of the following. e.g., FastQC, Bowtie2, SAMtools, NCBI BLAST+, Nextflow, etc.)
• Minimum of 1 year of experience with NGS, spanning knowledge and hands-on dry-lab experience.
• Scripting experience in coding languages (e.g., bash, awk, Python, R, etc.).
• A strong candidate would have Coding experience, papers published on coding, need next-gen sequencing analysis, and gene therapy.
• Degree in a relevant computer science discipline with a minimum of 3 years of relevant industry experience.
• Minimum of 1 year experience with NGS, spanning knowledge and hands-on dry-lab experience.
• Expertise in bioinformatics with a working understanding of genomic analysis solutions (e.g., FastQC, Bowtie2, SAMtools, NCBI BLAST+, Nextflow, etc.).
• Scripting experience in coding languages (e.g., bash, awk, Python, R, etc.).
• Understanding of NGS platforms, specifically those utilizing the synthesis by sequencing technique (i.e., Illumina platforms).
• Ability to work independently and adapt under aggressive and/or changing timelines.
• Familiarity with the software development lifecycle (e.g., Git).
• Automated unit testing for test-driven design (TDD).
• Familiarity with basic molecular biology techniques (e.g., ligation, PCR, and qPCR) as well as nucleic acid extraction and analysis techniques (e.g., Nanodrop, DNA fragment analyzers, ddPCR, etc.).
• Knowledge of and experience with other sequencing platforms (i.e., SMRT sequencing).
• Prior experience in leading the internalization of custom NGS analysis pipelines is highly preferred.
• Wet-lab method development experience to support NGS workflows.

Our client is a leading Pharmaceutical Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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Experienced VASCULAR ACCESS/CRITICAL CARE Nurses – Take Your Skills Beyond the Bedside

The Clinician Exchange (TCX) is looking for Per Diem Clinical Nurse Educators to support hospital go-lives and staff training for pharmaceutical and biotech clients.

Why you’ll love it:

• Flexible per diem schedule
• Travel opportunities across the U.S.
• No direct patient care
• Teach, mentor, and lead clinical education
• Join a network of 10,000+ clinician educators

What you’ll do:

• Educate hospital staff on medical devices
• Lead training sessions and provide onsite support
• Share your expertise in fast-paced clinical settings

What we’re looking for:

• RN with 5+ years of experience in vascular access or critical care
• Comfortable leading groups and teaching
• Strong communication and mentorship skills
• Passion for clinical education or medical devices
• Willing to travel

If you’re passionate about sharing your expertise, we’d love to hear from you!

About TCX

The Clinician Exchange (TCX) is a clinical concierge organization that delivers tailored commercial solutions for the medtech industry, both nationally and internationally. We empower medtech companies by helping them connect with their markets, demonstrate product value, and ultimately ensure that life-saving medicines reach the patients who need them. Our work includes supporting biopharma sales efforts to physicians and providing nurse educators to guide patients and prescribers.

About the Role

The ideal candidate has hands-on experience in Cesium chloride (CsCl) density gradient ultracentrifugation, ion-exchange chromatography, affinity purification, and tangential flow filtration (TFF), with a strong understanding of purification principles and data analysis.

Responsibilities

• Execute purification processes including CsCl density gradient ultracentrifugation, affinity chromatography (e.g., AVB, CaptureSelect), ion-exchange chromatography (AEX, CEX), and other polishing steps.
• Operate AKTA systems (Avant, Pure, or Pilot) for small- to large-scale purification runs.
• Perform TFF operations for buffer exchange and concentration of intermediate or final products.
• Support experimental design, data collection, and documentation following established procedures and GMP/GLP best practices.
• Assist in troubleshooting and optimization of purification processes.
• Analyze in-process and purified samples using relevant analytical methods (e.g., UV, SDS-PAGE, ddPCR, ELISA, or HPLC).
• Collaborate cross-functionally with upstream, analytical, and manufacturing teams.
• Maintain lab equipment, manage buffers and column inventory, and ensure compliance with safety and documentation standards.

Qualifications

• Education: Master’s degree in biology, biochemistry, chemical engineering, biotechnology, or related field.
• Experience: Minimum 2 years of hands-on purification experience in an academic or industry setting.

Required Skills

• Strong knowledge and practical experience with CsCl density gradient ultracentrifugation, ion-exchange, and affinity chromatography.
• Familiarity with buffer preparation.
• Understanding of basic analytical methods for product characterization.

Preferred Skills

• Strong attention to detail and excellent documentation habits.
• Effective communication and teamwork skills.
• Ability to manage multiple tasks and meet project timelines.

Preferred Qualifications

• Experience in AAV or other viral vector CsCl density gradient and column purification.
• Experience with AKTA systems and Unicorn software.