Chemistry Operations Manager Pharma Job at Amaris Consulting (Braine-L'alleud)

Non-Pharma Global Regulatory Affairs Manager

The Global Regulatory Sciences-Legacy Products-Non-Pharma Manager manages regula...

Location

Italy , Bologna; Milano; Pomezia

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Proven experience in Regulatory Affairs within the pharmaceutical or life sciences industry, preferably within the food supplements, medical devices, and cosmetics sectors
Hands-on experience with regulatory submission processes, especially within EU and/or RoW markets or similar relevant experiences
Demonstrated ability to coordinate projects or deliverables with complexity and limited supervision
Advanced degree in Life Sciences, Pharmacy, Chemistry, or a related field
Good knowledge of global regulatory frameworks including EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
Strong organizational skills, attention to detail, and ability to manage priorities
Collaborative mindset and effective communication with team members and stakeholders
Ability to operate independently on clearly defined assignments
Proficiency in Microsoft Office Suite and regulatory submission/document management tools
Fluent in English, both written and spoken

Job Responsibility

Accountable for providing the necessary regulatory inputs in a cross-functional team for the development of new projects
Accountable for the execution and implementation of global regulatory strategies by managing day-to-day activities for assigned products
Manage multiple regulatory workstreams independently, including authoring, reviewing and coordinating documentation for regulatory submissions such as variations, renewals and geo-expansions
Provide and review regulatory assessments for change controls and product updates
Responsible for the preparation, review and collection of documentation for submission and maintenance of Technical File and PTD for the project assigned
Provide critical review of documentation supporting regulatory applications
Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
Contribute to the preparation and presentation of regulatory project updates in internal meetings and governance committees
Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
Support other relevant assignments as directed by supervisor

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

IT Solutions Delivery Lead, R&D Operations

The IT Solutions Delivery Lead, R&D Operations role is critical to ensuring succ...

Location

United States , San Rafael

Salary:

112000.00 - 154000.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Bachelor of Science or greater in Computer Science, Business Administration, Information Technology, Biology, Chemistry or a related technical field or significant experience in supporting research systems in the pharmaceutical industry
Minimum of 5 years’ experience in technical or business analyst role with a focus on R&D functional systems and/or Information Technology
Experience in computer database management, programming, or software development familiar with developing Power Apps and Power Automate
Experience with Pharma/BioTech R&D systems such as SAS 9.4, SAS Viya, R-Studio, Phoenix WinNonLin, PumasAI, etc.
Data analysis expertise familiar with database technologies such as SQL, Oracle, Excel, Power BI, etc.
Delivering mid-to-large size projects with teams of 5 to 15 members on time and within budget
Have a general knowledge of the underlying scientific principles applied to the development and manufacture of biopharmaceuticals

Job Responsibility

System Ownership: Technical ownership of SAS 9.4, SAS Viya, R-Studio, Phoenix WinNonLin, PumasAI, etc.
Lifecycle Management of applications
Financial responsibility of all system operational expenses
Manage Software Vendors to ensure SLAs are met
Manage Licensing including budgeting and growth forecasting
Facilitate Application Steering Committees
Participate in change control boards and design review committees
Bridge the gap between business needs and technology constraints
Project Delivery: Support new application and system deployment projects
Participate as subject matter expert (and in some cases lead) projects

What we offer

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Fulltime

Senior Associate, R&D Lab Operations

The Senior Associate, R&D Lab Operations will apply their scientific background ...

Location

Denmark , Copenhagen

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor's or Masters Degree, preferably in Life Sciences, Chemistry or related field and preferably pharma-related lab operations
Fluency in English and Danish, written and oral communication

Job Responsibility

Support R&D laboratories and lab staff to deliver an end-to-end integrated laboratory management strategy
Assess facility needs and determine appropriate repair
Manage contractors and oversee facility repairs
Liaise with Amgen corporate Lab Operations and Facilities Management for complex projects
Support teams with contract renewals and invoice approvals for lab instrument service & lab consumables
Perform tactical lab duties: Refilling cell tank and NMR with LN2, Change out lab gas cylinders, Ensure lab consumables inventory is in place and in-lab point of use stations are stocked
Other duties as assigned
Support transformative lab projects (i.e. Laboratory Information Systems, Lab Equipment Management Systems, laboratory expansions, etc.)
Support the development and implementation of new optimizations and environmental & sustainability projects connected with laboratory workflow
Support teams with dry ice stocking, waste management, and documentation in collaboration with other supporting functions, e.g. local EHSS

What we offer

Comprehensive employee benefits package, including generous company pension contributions, life and disability insurance and private healthcare insurance.
A discretionary annual bonus program and stock-based long-term incentives
Competitive paid parental leave policy
Annual company-wide shutdown and additional vacation days
Flexible work model

Fulltime

Associate Manufacturing

The Manufacturing Associate position is part of the Amgen, Thousand Oaks, Drug P...

Location

United States , Thousand Oaks

Salary:

70985.20 - 96038.80 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school/GED + 2 years biotech/pharma manufacturing/laboratory or manufacturing support work experience
Associate's + 6 months biotech/pharma manufacturing/laboratory or manufacturing support work experience
Bachelor's

Job Responsibility

Performing 100% manual inspection
Post inspection packaging operation
Characterization and equipment management
Process improvement projects/assignments within operations
Quality systems (LIMS/MES/SAP/MAXIMO) support
Support new product introduction activities
Support clinical and commercial production
Maintain open communication between operations teams
Perform 100% manual inspection
Perform post manual inspection packaging operations

What we offer

Health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
Work/life balance
Career development opportunities
Comprehensive employee benefits package including Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program or sales-based incentive plan
Stock-based long-term incentives

Fulltime

New

Compliance Support Pharma

As a QA Specialist, Deviation Management, you will join the Compliance Support P...

Location

Belgium , Braine-L'alleud

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Master’s degree in biology, chemistry, biochemistry, engineering or related field OR Bachelor’s degree with strong, relevant experience
Minimum 2–3 years of experience in a GMP pharmaceutical environment
Experience in Fill & Finish / injectable manufacturing is highly preferred
Proven hands-on experience in deviation management (investigation, root cause analysis, documentation)
Strong knowledge of GMP and pharmaceutical manufacturing processes
Excellent writing skills (clear, structured, concise deviation reports)
Strong analytical and problem-solving mindset, structured and solution-oriented
Ability to be operational quickly and work independently on deviations (no junior profiles)
Mandatory and regular presence in production areas
Full compliance with GMP requirements: gowning procedures, hygiene rules, no jewelry/piercings, respect of classified zones

Job Responsibility

Perform impact assessments on product and process in case of deviations
Lead and execute investigations and root cause analyses
Prepare, write and maintain deviation documentation in compliance with internal procedures and GMP requirements
Ensure timely closure of deviations and contribute to the definition and follow-up of corrective and preventive actions (CAPA)
Be regularly present in production areas (Fill & Finish injectables)
Conduct on-the-floor investigations to collect facts and evidence
Perform Batch Record reviews, mainly in production zones, and ensure data integrity and compliance
Act as a key QA point of contact for production teams regarding deviations
Provide support during internal and external audits/inspections (e.g. health authorities, clients)
Prepare and organize deviation-related documentation for inspections

What we offer

Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe

Fulltime

New

Bd Executive

Drive growth at the heart of the UK's life sciences hub-connecting cutting-edge ...

Location

United Kingdom , London

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Degree in a science-related field (life sciences, chemistry, pharmacy, or related discipline preferred)
Proven experience in business development within pharmaceuticals, CRO/CDMO, drug development services, or life sciences consulting
Strong understanding of the drug development landscape, including CMC, clinical supply, manufacturing, and pharma services
Demonstrated success in winning new business and building long-term strategic relationships
Excellent communication, presentation, and negotiation skills
Self-motivated and comfortable working remotely with autonomy
Strategic approach to business development, balancing client value with sustainable revenue growth
Willingness and ability to travel regularly within the Golden Triangle and occasionally internationally

Job Responsibility

Identify, develop, and secure new business opportunities within the Golden Triangle region
Build and maintain strong relationships with biotech and pharmaceutical companies, ranging from early-stage startups to established organizations
Act as a trusted partner to clients, understanding their development needs and aligning them with company capabilities
Manage the full business development lifecycle, including lead generation, qualification, proposal development, commercial negotiations, and deal closure
Collaborate with internal teams such as sales, marketing, technical project management, and operations to deliver competitive and well-aligned proposals
Represent the organization at industry conferences, networking events, and client meetings
Maintain accurate pipeline management and forecasting using CRM tools
Provide market intelligence and competitor insights to support strategic growth initiatives

Fulltime

New

Manager, Technical Marketing CDMO

Drive growth at the intersection of science, strategy, and innovation! In Alfasi...

Location

Italy , Milano

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

MSc or PhD in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biotechnology, or related field
5–10 years experience in a CDMO, pharma, or biotech environment
Proven exposure to: Drug Product development and manufacturing processes, Technical customer interactions, Marketing, BD, or technical-commercial roles
Experience in one or more areas: Small molecules, biologics, peptides, or advanced modalities, Development, tech transfer, scale‑up, or commercial manufacturing
Strong understanding of CMC concepts and pharmaceutical lifecycle
Ability to quickly learn and position complex technologies
Value‑based selling mindset
Excellent storytelling and presentation skills
Customer‑centric approach with ability to tailor messaging
Strong written and verbal communication (English required)

Job Responsibility

Develop and maintain technical marketing materials (capability decks, product dossiers, white papers, case studies, videos, website content)
Translate complex CMC, manufacturing, and development capabilities into customer‑focused messages
Work closely with MSAT, R&D, Regulatory, Manufacturing, and Quality teams to ensure accuracy and consistency of content
Support positioning of services across drug substance, drug product, development, scale‑up, and commercial manufacturing
Partner with Business Development to support: Lead qualification and opportunity shaping, Customer presentations and technical pitches, RFI/RFP/RFQ technical inputs
Prepare customized customer‑specific value propositions aligned with development stage and therapeutic needs
Participate in customer meetings, scientific discussions, and technical calls as needed
Monitor CDMO market trends, competitor positioning, and emerging technologies
Analyze customer needs by modality, therapeutic area, and development phase
Provide insights to support portfolio strategy, investment decisions, and differentiation

What we offer

competitive salary
comprehensive benefits
extensive opportunities for professional growth and development

Fulltime

New

Quality Engineer Pharma with Dutch

As a MES Quality Engineer, you are responsible for the review and approval of Ma...

Location

Belgium , Geel

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Bachelor’s degree or higher in sciences (e.g., Chemistry, Biology, Pharmacy, Information Technology, Engineering, or related field)
4–6 years of experience (mid-level) in Chemical and/or Pharmaceutical Supply Chain and/or Quality Assurance
Strong understanding of production systems and their operation in a GMP environment
Proven track record of working independently while maintaining effective communication with key stakeholders
Proficiency with the PAS-X Manufacturing Execution System (MES) is MANDATORY
Strong analytical and critical thinking skills with a solutions-oriented mindset
High level of accuracy and attention to detail
Quality-focused mindset and strong sense of ownership and accountability
Excellent communication and stakeholder management skills
Fluent in Dutch and English

Job Responsibility

Review and approve Master Batch Records for commercial APIs
Review and approve MES Recipes, ensuring accuracy, consistency, and regulatory compliance
Write, review, and approve QA procedures and related documentation
Provide quality support for smaller optimization projects and continuous improvement initiatives within the QA Commercial Operations team
Ensure that MES-related changes are properly assessed from a quality perspective and implemented in a compliant manner
Collaborate closely with Production, Engineering, IT, and other Quality functions to resolve issues and optimize processes
Contribute to investigations, deviations, CAPAs, and change controls related to MES, Master Batch Records, and Recipes
Foster and maintain strong, collaborative relationships with Business and Quality partners across the site

Fulltime

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Chemistry Operations Manager Pharma

Job Responsibility

Requirements

Nice to have

What we offer

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