Senior Global CMC Manager (Development & Lifecycle) Job at Life Science Talent (Stockholm)

Senior CMC Manager, MSAT (Biologics)

Hansa Biopharma is seeking an experienced Manufacturing Science & Technology exp...

Location

Sweden , Lund

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

M.Sc (or equivalent) in Pharmaceutical Sciences, Biochemistry, Biotechnology, Chemistry, Engineering, or related life science field
Typically, 8+ years of experience in GMP manufacturing of biologics
Demonstrated in-depth scientific understanding of biologics manufacturing processes (e.g., recombinant proteins, enzymes, monoclonal antibodies or similar)
Extensive experience supporting both clinical development and commercial manufacturing
Solid hands-on experience working within GMP-regulated quality systems
Proven track record in oversight of CDMOs/CMOs in a virtual or outsourced manufacturing structure
Experience interacting with global health authorities and supporting regulatory inspections
Strong understanding of regulatory expectations for biologics throughout the product lifecycle
Excellent communication skills in English

Job Responsibility

Act as the recognized internal SME for CMC Quality related to biologics and GMP compliance for biological drug substance and drug product manufacturing
Strengthen and continuously improve CMC quality systems, promoting a proactive, science-based, and compliance-driven quality culture while identifying process improvement opportunities
Coordinate and manage deviation investigations, change controls, CAPAs, and risk assessments
Contribute to, and support, interactions with regulatory authorities (e.g., FDA, EMA)
Review and approve Master Batch Records, protocols, validation documentation, and technical reports
Provide robust quality oversight of CDMOs, CMOs, and CROs, including supplier qualification, performance monitoring (KPIs), and continuous improvement initiatives
Act as vendor responsible and perform periodic Vendor review
Contribute to the establishment and maintenance of Quality Agreements

Fulltime

Head of Global Regulatory Affairs CMC

This position is responsible for defining and executing global regulatory strate...

Location

Italy , Bologna; Milan; Pomezia

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

15+ years of experience in regulatory affairs with strong focus on CMC
Deep expertise in global CMC regulatory requirements (FDA, EMA, ICH guidelines)
Proven leadership of global teams and complex regulatory programs
Demonstrated success in major filings and global product approvals
Advanced degree in chemistry, pharmacy, chemical engineering, or related scientific discipline (PhD preferred)
Strategic regulatory leadership and decision-making
Deep CMC scientific and technical expertise
Strong understanding of pharmaceutical manufacturing processes
Health authority interactions and relationship management
Proven ability to be hands-on, agile and lead organizational efforts and innovation by example

Job Responsibility

Define and lead global regulatory CMC strategies and execution for development, registration, and post-approval lifecycle management, leveraging frameworks such as RELIANCE where appropriate
Ensure alignment of CMC regulatory approaches with overall product development and commercialization strategies, partnering cross-functionally to ensure aligned approach
Provide strategic input into critical development milestones (e.g., IND/CTA, BLA/NDA, MAA)
Oversee the development of high-quality CMC regulatory dossiers, including Module 3 content and supporting documentation, including rigor in CMC regulatory justifications, control strategies, comparability, and specifications
Ensure alignment with ICH guidelines and evolving regulatory science expectations, proactively communicating these and their impact for Alfasigma across the organization
Lead regulatory support for manufacturing changes, site transfers, scale-ups, and technology transfers
Serve as the senior regulatory CMC representative in interactions with global health authorities (e.g., FDA, EMA)
Establish global frameworks for CMC change management, ensuring compliance and minimizing regulatory risk
Drive efficient handling of complex changes (e.g., process improvements, new technologies, dual sourcing)
Ensure global alignment and consistency across markets

What we offer

competitive salary
comprehensive benefits
extensive opportunities for professional growth and development

Fulltime

Senior Process Engineer

In this role, you will get the opportunity to work with committed colleagues in ...

Location

Sweden , Lund

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

At least 7 years of experience from pharmaceutical manufacturing operations
Master’s degree in Engineering, Life Sciences, or a related scientific discipline
Hands-on experience from manufacturing process development, technology transfer, and GMP-regulated pharmaceutical manufacturing, preferably within sterile or injectable products
Fluency in spoken and written English

Job Responsibility

Lead technology transfers of injectable pharmaceutical products from development into commercial manufacturing at CMOs
Partner with R&D to ensure that formulation and process development activities support successful scale-up, manufacturability, and long-term process robustness
Provide technical support for process development, scale-up, validation, and commercial manufacturing activities at CMOs
Act as technical lead for investigations and troubleshooting of process deviations, OOS results, manufacturing failures, and other complex technical challenges
Contribute to CMC documentation in support of global regulatory submissions and product lifecycle management
Ensure that manufacturing processes are executed in accordance with applicable GMP requirements and regulatory expectations

What we offer

International work environment and corporate culture
Possibility for individual development and growth
Great opportunities to influence
Work together with highly competent colleagues, caring for each other

Fulltime

Regulatory Affair Director - Global Regulatory Leader (Rare Disease)

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part...

Location

United States

Salary:

189632.45 - 256561.55 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of directly related experience
Master's degree and 8 years of directly related experience
Bachelor's degree and 10 years of directly related experience
at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources

Job Responsibility

Develops Global Regulatory Strategic Plan through integration of regional regulatory strategies and provide regulatory input into the Global Strategic Plan
Represents GRA on PT and EGT to ensure development of product registration strategies and development plans aimed at achieving regulatory approval and product labeling
Provides regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent
Leads development, review and approval of the target product label (TPL)
Obtains input from the GRT members (e.g. RRLs, RA CMC, Safety, etc.) to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance
Leads the planning and implementing global regulatory filings (e.g. clinical trial applications, marketing applications, label extensions, CMC changes)
Ensures consistency of evidence-based global product communication (e.g. regulatory submission documents)
Conducts contingency regulatory planning/risk assessment for global product development strategies and agency interactions
Monitors and assess impact of relevant global regulations, guidances, and current regulatory environment
Ensures guidance on regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug Designation, Breakthrough Therapy or PRIME designations, Fast Track, conditional /accelerated approval, compassionate use and pediatric plan) are assessed and incorporated into the global regulatory strategy

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Regulatory Project Manager

At GSK, we’re constantly developing new products and improving our established m...

Location

Poland , Poznan; Warsaw

Salary:

236250.00 - 393750.00 PLN / Year

GSK

Expiration Date

Until further notice

Requirements

Advanced degree (Master's or above) in Pharmacy, Biotechnology, Biology, Chemistry/Biochemistry or other closely related medical/life science field
Strong experience in CMC Regulatory Affairs within pharmaceutical industry or research organization
Extensive expertise in regulatory strategy planning, dossier preparation (CTD Module 1-3), technical dossier review and in all associated CMC regulatory aspects
Sound understanding of the pharmaceutical industry, drug development environment, regulatory processes and ICH guidelines and requirements, including EU regulatory framework
Exceptional flexibility, analytical thinking and growth mindset
Excellent interpersonal skills
including clear and effective written and verbal communication, and the ability to build strong relationships across a diverse, large organization
English writing skills
Excellent organizational skills, ability to handle multiple tasks, prioritize effectively and deliver high quality output under imposed deadlines, with a strong attention to detail (with emphasis on accuracy and completeness)

Job Responsibility

Take ownership for multiple complex CMC regulatory submissions, including planning, coordination and execution, to support applications for marketing authorizations, lifecycle activities and maintenance of registered products across Vaccines portfolio, in accordance with the applicable regulatory and scientific standards
Manage multiple project assignments simultaneously, including CMC variations and handling Health Authority Questions (HAQs) for Finished Products, Intermediates, and Active Pharmaceutical Ingredients for Vaccines products (i.e. largely involving updates to the CTD Module 3, Quality section of the dossiers)
Identify risks associated with submission data and information package
and support the development of mitigation strategies
Collaborate closely with cross-functional teams, such as Global Regulatory Lead’s team, Global Supply Chain (GSC), Quality Assurance (QA), Local Operating Companies (LOCs), and third Parties to build regulatory CMC submissions and maintain strong relationships, including with senior stakeholders
Identify improvement opportunities for CMC Regulatory processes, policies, instructions and systems, developing and implementing simplified working practices and procedures to enhance efficiency and quality
Serve as Subject Matter Expert (SME) for CMC Regulatory Affairs, mentoring and guiding team members, while sharing best practices to build capability and knowledge within the CMC Regulatory teams and other impacted functions

What we offer

private healthcare
additional paid days off
life insurance
private pension plan
fully paid parental leave & care of family member leave

Fulltime

Accountant

We are seeking a detail-oriented Accountant to support daily accounting operatio...

Location

United States , Miami

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Accounting, Finance, or related field
2+ years of accounting experience
Knowledge of general accounting principles and financial reporting
Experience with general ledger, reconciliations, and close processes
Proficiency in Microsoft Excel and accounting software or ERP systems
Strong attention to detail, organization, and problem-solving skills
Ability to work independently and collaboratively in a team environment
Strong written and verbal communication skills

Job Responsibility

Prepare and record journal entries, accruals, and adjustments
Maintain and reconcile general ledger accounts
Perform monthly bank and account reconciliations
Assist with month-end, quarter-end, and year-end close
Prepare financial statements, reports, and supporting schedules
Analyze account activity and investigate discrepancies
Support accounts payable, accounts receivable, and payroll processes as needed
Help ensure compliance with company policies, internal controls, and accounting standards
Assist with audits by preparing documentation and responding to requests
Contribute to budgeting, forecasting, and variance analysis

What we offer

medical insurance
vision insurance
dental insurance
life insurance
disability insurance
401(k) plan

Fulltime

Critical Environment Technician Manager

In alignment with our Microsoft values, we are committed to cultivating an inclu...

Location

United States , Mount Pleasant

Salary:

75400.00 - 167900.00 USD / Year

Microsoft Corporation

Expiration Date

Until further notice

Requirements

High School Diploma, GED, or equivalent AND 3+ years mission critical services work/applied learning experience (e.g., high availability assembly/manufacturing/critical infrastructure environments such as data centers, oil and gas refineries, hospitals, pharmaceutical, manufacturing, or related fields) OR equivalent experience
Ability to work shifts, including shift assignments during non-standard business hours that may include evening, nighttime, weekends, and/or holidays
Ability to meet Microsoft, customer and/or government security screening requirements are required for this role
High School Diploma, GED, or equivalent AND 6+ years mission critical services experience OR Associate's Degree or technical trade certification (e.g., military, trade school), or higher-equivalent education AND 5+ years mission-critical services experience OR equivalent experience
1+ year(s) people management experience
1+ year(s) experience in a specialized area (e.g., mechanical field, electrical field, controls field) or related field

Job Responsibility

People Management: Managers deliver success through empowerment and accountability by modeling, coaching, and caring. Model - Live our culture
Embody our values
Practice our leadership principles. Coach - Define team objectives and outcomes
Enable success across boundaries
Help the team adapt and learn. Care - Attract and retain great people
Know each individual’s capabilities and aspirations
Invest in the growth of others
Equipment and Systems Operations: Serve as an operations specialist one or more major area of operations (e.g., electrical, mechanical, controls, generators, and work on advanced tasks independently. Oversee and coach team with the inspection of critical environment-related facility equipment (e.g., controls, heating, ventilation, and air conditioning [HVAC], mechanical systems), building, and grounds regularly for unsafe or abnormal conditions to develop and analyze trends. Monitor performance of maintenance and operations utilizing telemetry, control systems, and other platforms and is able to identify all alarms. Utilize internal computerized maintenance management system (CMMS) to track all equipment assets and to complete work order requests for maintenance work and generate reporting to identify outstanding and ongoing work orders. Safely and quickly respond to and lead an onsite incident response team for all abnormal conditions that impact operations and coordinate with other critical facilities professionals to perform corrective repairs. Enhances, develops new, or follows preexisting emergency operating procedures (EOPs), methods of procedure (MOPs), and standard operating procedures (SOPs) in relation to incidents. Gathers necessary information and creates incident timelines/data, root-cause analyses, and/or action items following an abnormal condition
Equipment and Systems Maintenance: Guide, oversee, and perform various types of maintenance (e.g., planned, predictive, corrective) and repairs following methods of procedure (MOPs), and standard operating procedures (SOPs) for one or more disciplines and one or more types of equipment (e.g., electrical, mechanical, cooling systems) and escalate when appropriate. Serve as a subject matter expert for one type of equipment and oversee everyday tasks and troubleshooting within their area of expertise. Have a hands-on understanding of how equipment works within disciplines they have been trained and how to troubleshoot equipment, systems, subsystems, and components independently within their trained discipline(s). Provide and/or assign team to provide necessary escort to third-party contractors, sub contractors, vendors, and service providers on site for all severity leveled procedures. Coordinate and schedule supplier/vendor on-site activities and recognizes circumstances when to stop supplier work to address potential and/or identified concerns. Take part in getting third-party work underway (e.g., making sure systems are properly energized/deenergized), ensuring the work is started and completed in a safe manner in accordance with standard practices, procedures, federal/local legislation, and municipal codes. Advises junior colleagues on inspection and supervision issues. Provides consultation to lower-level colleagues in troubleshooting systems and problems
Critical Environment Culture: Understands, follows, ensures, and coaches team on safety and security requirements (e.g., job hazard assessments [JHAs], toolbox talks), and business processes and procedures to properly perform work in a safe, quality, and reliable manner in accordance with applicable federal, state, local, and Microsoft requirements. Proactively ensures safety and security requirements are followed and met for the work of themselves and others. Maintain safe working conditions and escalate immediately when unsafe working conditions are observed. Assesses and identifies appropriate resources and equipment necessary to fully support environmental health and safety (EH&S) objectives. Participates in required meetings, trainings, and necessary handoffs

What we offer

Benefits and other compensation (details at https://careers.microsoft.com/us/en/us-corporate-pay)

Fulltime

Psychologist/Psychological Assessment and Evaluation

Join a clinician-centered multidisciplinary team of counselors, social workers, ...

Location

United States , Georgetown

Salary:

Not provided

Ellie Mental Health

Expiration Date

Until further notice

Requirements

Clinical licensure is required (PhD or PsyD)
Experience with completing diagnostic evaluations, scoring and interpreting results, writing reports that clients can understand, and providing feedback to clients
Comfort and familiarity working with a diverse client base from an affirming perspective
Candidates must be able to work in Maryland with a Maryland license, or be license-eligible
Opportunity to provide supervision to psychology associates and trainees for qualified candidates with a demonstrated history of success with Ellie

Job Responsibility

Completing diagnostic evaluations
Scoring and interpreting results
Writing reports that clients can understand
Providing feedback to clients
Providing supervision to psychology associates and trainees for qualified candidates

What we offer

Competitive salary
Flexible schedule
Opportunity for advancement
Health insurance
PTO
Weekly case consultation groups
Free CEUs
Monthly team activities focused on clinician well-being
We will cover all testing costs and expenses as well as administrative tasks like marketing, scheduling, and billing
Cash pay service: clients pay upfront, and you’ll earn 50% of what we collect

Fulltime

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Senior Global CMC Manager (Development & Lifecycle)

Job Description

Job Responsibility

Requirements

What we offer

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