Skip to content
CV Rocket
Get started
How it worksThe enginePricingBlogContactSign in

Open nowFirst seen 2 days ago

Manager, Technical Operations

BioReference Health LLC2 open roles

Where
WESTON, MA, USA
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowManager, Technical OperationsBioReference Health LLC · WESTON, MA, USA

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on BioReference Health LLC's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 58.1%60 days
This job: first seen 2 days ago

The posting

ModeX Therapeutics, an OPKO Health company, is the leading clinical-stage biopharmaceutical company developing unique and proprietary multispecific therapeutics. Its MSTAR platform unites the power of multiple biologics in a single molecule to create multispecific antibodies that bind four or more targets with unprecedented versatility and potency for complex diseases. Its promising first-in-class immunology pipeline includes candidates against immune diseases, including cancer (both solid and hematologic tumors), immune impairment, as well as several of the world’s most pressing viral threats. Its founding team includes globally recognized medical innovators with proven track records of delivering breakthroughs for patients. ModeX is based in Weston, Massachusetts. For more information, please visit www.modextx.com.

Job Summary

The Manager, Technical Operations provides operational leadership for CMC development and clinical supply activities across global development programs. This individual serves as the functional owner for key Technical Operations outsourced and in-house processes, including stability and supply chain activities, while driving cross-functional alignment among internal and external stakeholders. The role is responsible for operational planning and execution including risk management and continuous improvement initiatives that support the successful CMC development and supply of clinical-stage products. This is a manager-level individual contributor position requiring strong technical judgment, commitment to quality, and the ability to influence outcomes. The ideal candidate is highly organized, detail-oriented, data-driven, and committed to operational excellence and accuracy.

Why Join Us?

In this job you will play a pivotal role in advancing innovative biologic therapies from development through clinical execution. This is an opportunity to build and lead stability and clinical supply strategies that directly influence product development, regulatory milestones, and patient access to investigational therapies.

What Makes This Role Unique

High-impact decision making

  • Lead stability programs, shelf-life assessments, and clinical supply strategies that directly influence development timelines and clinical trial success.
  • Use scientific and operational judgment to guide critical decisions on inventory utilization, expiration dating, and supply continuity.

Broad visibility and influence

  • Partner closely with senior leaders across CMC, Quality, Regulatory Affairs, Clinical Operations, and external development partners.
  • Present recommendations and risk assessments that shape program strategy and business decisions.

Ownership across the product lifecycle

  • Drive stability and clinical supply activities from early clinical development through late-stage programs.
  • Lead initiatives spanning analytical testing, stability studies, packaging, labeling, global distribution, and inventory management.

Work on innovative therapies

  • Support cutting-edge biologic development programs addressing significant unmet patient needs.
  • Contribute to complex development challenges involving novel modalities, cold-chain logistics, and global clinical supply networks.

A collaborative and entrepreneurial environment

  • Join a growing organization where expertise, initiative, and problem-solving are highly valued.
  • Work in a highly cross-functional setting where individuals are empowered to make meaningful contributions and drive change.

Professional growth

  • Expand your technical and strategic leadership capabilities through exposure to multiple development programs, regulatory interactions, and global clinical operations.
  • Build a foundation for future leadership opportunities across Technical Operations, CMC, Supply Chain, and Product Development.

Who Will Thrive Here

This role is ideal for candidates who enjoy combining scientific rigor with operational leadership, are energized by solving complex development challenges, and want to make a visible impact on the advancement of innovative therapies and clinical programs.

Core Responsibilities

  • Lead CMC operational activities supporting global clinical development programs across drug product, analytical, stability, packaging/labeling, storage, logistics, and distribution functions.
  • Lead planning and execution of stability programs and shelf-life extension activities, including data review, trend analysis, risk assessment, and recommendations to support program decisions.
  • Develop and maintain DP inventory plans and supply strategies to ensure uninterrupted support of global clinical studies.
  • Serve as the primary operational lead for testing, stability, and supply chain activities at CDMOs, CROs, and other external partners, ensuring alignment on timelines, deliverables, and quality expectations. Monitor partner performance, facilitate issue resolution, and support business reviews to drive operational excellence.
  • Evaluate analytical and stability data to identify trends, assess operational and technical risks, and develop mitigation strategies to support program success.
  • Collaborate with CMC leaders to maintain CMC operational plans, timelines, dashboards, metrics, risk registers, and management reporting to support informed and proactive decision-making.
  • Lead operational readiness activities for analytical testing, clinical supply production, and distribution activities.
  • Drive continuous improvement initiatives focused on operational efficiency, data management, business processes, and documentation practices.
  • Identify, assess, and proactively manage supply chain challenges and operational issues that may impact project timelines or clinical supply availability.
  • Collaborate with CMC, Clinical Operations, Program Management and external partners to track deliverables, communicate status, and escalate issues to leadership.
  • Support CMC activities by preparing program updates, risk assessments, mitigation plans, and decision-support materials for leadership and cross-functional teams.

Qualifications

  • MS or PhD in Pharmaceutical Sciences, Biotechnology, Chemical Engineering, Analytical Chemistry, or a related scientific discipline, with 5+ years of biopharmaceutical industry experience supporting clinical-stage development programs; or a BS in a related scientific discipline with 10+ years of relevant industry experience.
  • Demonstrated experience leading complex CMC operational activities and cross-functional initiatives within a regulated environment.
  • Understanding of biologics development, clinical manufacturing, analytical testing, stability programs, and clinical supply operations.
  • Experience supporting clinical supply planning, inventory management, batch disposition activities, and external development and manufacturing partners.
  • Proven ability to independently manage multiple programs, priorities, and external partners while driving execution against established objectives.
  • Experience reviewing and interpreting technical documentation, manufacturing records, protocols, reports, investigations, and change controls to identify risks, and develop practical mitigation strategies.
  • Strong project management, organizational, and influencing skills, with the ability to facilitate alignment across diverse stakeholder groups.
  • Excellent communication and presentation skills, including experience presenting recommendations and program status to senior leadership.

ModeX Therapeutics is an Equal Opportunity Employer

ModeX Therapeutics, an OPKO Health company, is the leading clinical-stage biopharmaceutical company developing unique and proprietary-multispecific therapeutics. Its MSTAR platform unites the power of multiple biologics in a single molecule to create multispecific antibodies that bind four or more targets with unprecedented versatility and potency for complex diseases. Its promising first-in-class immunology pipeline includes candidates against immune diseases, including cancer (both solid and hematologic tumors), immune impairment, as well as several of the world's most pressing viral threats. Its founding team includes globally recognized medical innovators with proven track records of delivering breakthroughs for patients. ModeX is based in Weston, Massachusetts. For more information, please visit www.modextx.com.

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against BioReference Health LLC's own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on BioReference Health LLC's form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    BioReference Health LLC's answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

Get the CV for this job
By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.