Jobs in Winthrop Massachusetts

About the Company

We are seeking an experienced Director, Regulatory CMC to provide strategic and operational leadership for Chemistry, Manufacturing, and Controls regulatory activities across a growing portfolio of development and commercial products. This role will serve as the CMC regulatory subject matter expert, ensuring compliance with global regulatory requirements while supporting efficient development, manufacturing, and lifecycle management. The Director will work closely with Technical Operations, Quality, Manufacturing, and Development teams and will represent CMC Regulatory in interactions with health authorities.

About the Role

This role will serve as the CMC regulatory subject matter expert, ensuring compliance with global regulatory requirements while supporting efficient development, manufacturing, and lifecycle management.

Responsibilities

• Lead the global CMC regulatory strategy for development and marketed products, ensuring alignment with business objectives and regulatory expectations.
• Provide oversight and authorship for CMC sections of regulatory submissions, including INDs/CTAs, BLAs/NDAs, supplements, variations, and annual reports.
• Act as the primary CMC regulatory representative in health authority interactions, including FDA meetings, scientific advice, and regulatory correspondence.
• Support CMC lifecycle management, including comparability assessments, post-approval changes, and regulatory impact evaluations.
• Partner cross-functionally with Technical Operations, Manufacturing, Quality, Analytical Development, and Supply Chain to ensure regulatory compliance and readiness.
• Ensure compliance with ICH guidelines, FDA, EMA, and other global regulatory requirements applicable to CMC activities.
• Contribute to internal governance forums, risk assessments, and regulatory decision-making processes.
• Build and maintain effective relationships with external partners, including CDMOs and regulatory consultants.
• Mentor and develop regulatory staff as appropriate, supporting a culture of regulatory excellence and accountability.

Qualifications

• 10+ years of Regulatory Affairs experience, with significant focus on CMC in pharmaceutical or biotechnology environments.
• Bachelor’s degree in a scientific discipline required; advanced degree (MS, PhD, PharmD) preferred.
• Demonstrated experience supporting IND, BLA, or NDA submissions, including CMC sections.
• Strong working knowledge of global CMC regulatory frameworks (FDA, EMA, ICH).
• Experience collaborating with manufacturing, quality, and technical operations organizations.
• Proven ability to operate effectively in an SME environment, balancing strategic oversight with hands-on execution.
• Excellent written and verbal communication skills, with the ability to clearly convey regulatory requirements and risk.

Required Skills

Strong working knowledge of global CMC regulatory frameworks (FDA, EMA, ICH).

Preferred Skills

Experience collaborating with manufacturing, quality, and technical operations organizations.

Pay range and compensation package

Competitive compensation and comprehensive benefits.

Equal Opportunity Statement

We are committed to diversity and inclusivity.

Freelance Sales Director Global Technology Staffing & Remote Workforce

Location: Boston, Massachusetts, United States

Experience: 8+ Years

People Prime is a global talent solutions company specializing in helping organizations build high-performing technology teams through Remote hiring, Staff augmentation, and Offshore delivery models.

Headquartered in India, People Prime connects companies worldwide with highly skilled technology professionals across emerging and advanced digital domains. We enable organizations to scale faster by providing access to a curated network of experienced engineers, AI specialists, data professionals, and technology consultants who can work remotely or as part of distributed global teams.

People Prime focuses on enabling companies to hire high-quality remote technology talent from India, one of the world’s largest and fastest-growing technology talent markets. Through our strong recruitment ecosystem and technical screening process, we provide organizations with access to professionals across a wide range of digital and enterprise technologies.

1. Artificial Intelligence & Machine Learning: Machine Learning Engineers: Generative AI Engineers: Prompt Engineers: Natural Language Processing (NLP) Specialists: Computer Vision Engineers: AI Model Training & Fine-Tuning Experts
2. Data Engineering & Analytics: Data Engineers, Data Architects: Data Scientists: Big Data Specialists, Data Platform Engineers: Analytics & BI Professionals
3. Cloud & DevOps: Cloud Architects (AWS, Azure, GCP): DevOps Engineers: Platform Engineers, Kubernetes Specialists: Infrastructure Automation Experts
4. Software Engineering: Full Stack Developers: Backend Engineers: Frontend Engineers: Mobile Application Developers: Microservices & API Developers
5. Enterprise Platforms: SAP Consultants: Salesforce Experts: ServiceNow Professionals: ERP & Digital Transformation Specialists

Key Responsibilities:

• Identify and acquire new clients seeking technology staffing or remote engineering teams

• Generate opportunities for contract staffing, staff augmentation, and distributed engineering teams

• Develop relationships with technology companies, startups, and enterprise clients

• Present People Prime’s global talent and offshore delivery capabilities

• Build and manage a strong pipeline of staffing opportunities

• Collaborate with delivery and recruitment teams in India to fulfill client requirements

• Negotiate client contracts, rate cards, and service agreements

• Track hiring trends in AI, data engineering, cloud, and software development

Required Qualifications:

• 8+ years’ experience in IT staffing business development or recruitment sales

• Proven track record of generating staffing opportunities and closing new clients

• Strong network within technology companies, startups, or enterprise organizations

• Experience selling staff augmentation or contract staffing services

• Excellent communication, negotiation, and relationship management skills

Preferred Experience:

• Experience selling offshore technology talent or remote engineering teams

• Exposure to hiring in AI, data engineering, cloud, or software development domains

• Understanding of distributed workforce and remote hiring models

Success Metrics:

Success in this role will be measured by:

• New client acquisitions

• Remote staffing requirements generated

• Revenue from staffing engagements

• Successful onboarding of consultants

• Client retention and satisfaction

Performance expectation:

Minimum 4 Contract placements per month

Compensation:

USD 1500 Payable on Every AI/ Technology Contractor Successful onboarding ( Minimum 5 Onboards Expected Every Month )

6% of gross margin for the first 6 months of each engagement

Why Join People Prime:

• Sell high-demand global technology talent solutions

• Work with a scalable offshore delivery model with great cost advantage to clients

• High earning potential with strong commission structure

• Exposure to fast-growing sectors such as AI, cloud, and data engineering

• Opportunity to build long-term partnerships with global technology companies

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.

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.

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.

Executive Assistant to the CEO, CFO and C-Suite Team, Boston, Mass, Hybrid

A global and innovative energy solutions company is seeking an exceptional Executive Assistant to serve as a true “right hand” to the CEO, CFO as well as help others on the C-Suite team with some administrative work. This is not a traditional administrative role, but a relational, and trust-based partnership designed to amplify the CEO's CFO’s effectiveness, clarity, and presence. The Executive Assistant will act as a stabilizing force, thoughtful gatekeeper, and intuitive collaborator, someone who understands not only what needs to be done, but how and when to do it in a way that respects people and priorities. Excellent skills using AI is a MUST as well as a “can do” problem solving persona. This is 3 or 4 days in the office depending on what is going on.

About the Job:

Trusted Partner & Strategic Support

• Act as a thought partner and sounding board, offering perspective, feedback, and quiet counsel when needed.
• Anticipate needs and proactively remove friction before issues arise.
• Prepare the CEO/CFO for meetings and conversations with context and background information; leverage AI to draft, summarize analyze and prepare materials.

Time, Energy & Focus Management

• Manage a complex and fluid calendar with an understanding of priorities and relationships, .
• Protect the CEO and CFO’s time by thoughtfully filtering requests and creating space for strategic thinking.
• Coordinate domestic and international travel including detailed itineraries.

Communication & Relationship Management

• Serve as a warm, professional liaison between the CEO/CFO and internal teams, partners, and external stakeholders.
• Draft and manage correspondence on the CEO and CFO’s behalf, ensuring tone, values, and intent are consistently reflected.

Information Flow & Follow-Through

• Distill information into clear, actionable insights for the CEO and CFO; create and edit PowerPoint presentations.
• Track commitments, decisions, and follow-ups to ensure momentum and accountability.
• Support special projects and initiatives that require coordination, and thoughtful execution.
• Plan quarterly meetings and events, dinners

About You

• Bachelor’s degree required.
• At least 5 years of experience supporting busy C-Suite executives, preferably in the tech or finance space and someone who thrives in a start- up type firm mentality.
• Strong written and verbal communication skills.
• High proficiency with Microsoft Office Suite
• Up to date and use AI Tools for daily work to increase productivity and improve processes
• Handle highly sensitive information with absolute discretion.
• High emotional intelligence and sound judgement.
• You thrive in ambiguity and are energized by anticipating needs rather than reacting to them.
• You value discretion, loyalty, and long-term partnership.
• You are highly organized, detail-oriented, and capable of managing multiple priorities without losing sight of the human element.
• You communicate with warmth, clarity, and confidence You bring polish and presence, while remaining grounded and approachable with a “high touch” service and team mentality.
• Base Salary, Discretionary Bonus, 100% Medical Health Care Coverage for Employee, Unlimited PTO

Trueline’s client, a rapidly growing restoration services provider in the Greater Boston area, is seeking a Lead Technician – Water & Fire Restoration to join their on?site team in Boston, MA. This role combines hands?on restoration work with customer communication and team coordination, offering a fast?paced environment and opportunities for professional growth.

What You’ll Do as the Lead Technician – Water & Fire Restoration:

• Lead on?site restoration efforts—from mitigation and demolition to drying and sanitation.
• Set up and monitor drying equipment, using moisture meters to assess and document progress.
• Act as a primary point of contact for customers—clearly explaining the process and next steps.
• Maintain job­site inventory of tools, materials, and equipment.
• Uphold best practices in safety and industry standards throughout each project.
• Coordinate closely with office staff and project managers for scheduling and updates.

Must?Haves as the Lead Technician – Water & Fire Restoration:

• 3–5 years of hands?on experience in water, fire, or mold restoration work.
• Familiarity with restoration equipment and standard mitigation techniques.
• Valid driver’s license with a clean driving record.
• Physical ability to lift 50+ lbs and work safely in varied environments (e.g., crawlspaces, attics, outdoors).
• Strong communication and organizational skills.

Nice?to?Haves as the Lead Technician – Water & Fire Restoration:

• IICRC Water Damage Restoration (WRT) certification or similar credentials.
• Prior leadership or supervisory experience on restoration sites.

Our Client Offers:

• $30/hour, paid weekly, with overtime opportunities.
• Company vehicle provided for job?site commute.
• Paid training and support for certification advancement.
• Clear potential for career growth within a fast?expanding organization.

Trueline and its clients are unabashed equal?opportunity employers committed to a diverse workforce. We welcome smart and ambitious applicants and recruit, refer, hire, place, and promote without regard to race, color, gender, religion, national origin, ancestry, citizenship, disability, age, sexual orientation, or any other characteristic protected by federal or state law.