Biopharmaceutical Specialist Job at Amgen (Taipei)

GMP QC Specialist, CMC

Reporting to the Director, QA Operations, the GMP QC Specialist, CMC, will be re...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in scientific discipline
Advanced degree preferred
Minimum of 5 years’ hands-on experience in biopharmaceutical technical operations, QC operations and/or quality operations
Minimum of 2 years’ hands-on experience in GMP laboratory environment, with specific familiarity with cell and gene therapy release assay development, performance, and qualification
Specific experience performing or reviewing microbiological assays, including compendial methods (sterility, endotoxin, mycoplasma assays, APS, APV and Environmental Monitoring)
Experience interacting with external testing laboratories preferred
Working knowledge of GMP and ICH guidance and both US and international regulatory requirements
Highly organized, effective, and proactive communicator verbally and in writing. Able to work independently to appropriately prioritize work
Strong team orientation and passion for continuous self-development
Experience in industry or in a startup industrial setting is preferred

Job Responsibility

GMP Compliance: Ensure that all internal laboratory activities are maintained in accordance with internal data integrity practices and standards. Ensure that external laboratory activities comply with GMP regulations and guidelines. Stay current with regulatory requirements and industry standards related to GMP
Batch Review / Release: Perform full batch record review of all types of investigations
perform appropriate quality control review of all QC data generated by third parties
draft, review, and approve CoA (internal/external)
Investigations: Identify issues of non-compliance and work directly with the third party to resolve prior to batch release. Review and approve any out-of-specification investigations in a timely manner
Quality Control Procedures: Develop, implement, and maintain quality control procedures to monitor and assess internal laboratory processes, as well as the processes employed by external laboratories used to generate QC data. Conduct regular reviews to identify areas for improvement and initiate corrective action(s) as needed
Audits and Inspections: Assist in the planning and conducting of internal audits to assess compliance with data integrity standards and approved procedures (e.g. SOPs, test methods). Support audits of external laboratories as needed
Assay Qualification / Validation: Review and approve assay development, qualification and validation plans, data generated and reports. Provide primary QC support for all activities
Documentation Management: Oversee the creation, review, and approval of laboratory documentation, including SOPs, test methods, protocols, and reports. Ensure that the documentation is accurate, complete, and in compliance with GMP requirements. Ensure all Process Development (Analytical Development and Manufacturing Sciences & Technology) related documentation and data are reviewed and archived in a timely and accurate manner
Training and Education: Assist in providing training and guidance to Process Development personnel on GMP principles, procedures, and compliance requirements. Ensure that all team members are informed and adhere to quality control measures

What we offer

health and retirement
PTO
stock option plans

Biopharmaceutical Specialist- Oncology (CRC/LC Focus)

The Biopharmaceutical Specialist – Oncology (CRC/LC Focus) is a pivotal role in ...

Location

Taiwan , Taipei

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Minimum 3 years of pharmaceutical sales experience, preferably in Oncology, with CRC/LC experience strongly preferred
Bachelor's degree in science or medical-related field, preferably with higher qualifications in pharmacy science
Demonstrated growth mindset, strategic thinking, and results orientation
Strong cross-functional collaboration, and communication skills
Proactive, enthusiastic, and creative approach, with a strong ability to take initiative
Fluency in English for both oral and written communication
Proficient in computer skills, including MS Office programs

Job Responsibility

Achieve sales target of responsible hospital assigned oncology accounts with a primary focus on CRC/LC-related hospitals and key centers
Establish and maintain high-quality customer relationships
Coordinate and implement scientific events aligned with marketing strategy
Demonstrate in-depth knowledge of oncology diseases (with emphasis on CRC/LC), products, market, stakeholders, and competitors
Attend required training sessions, obtaining necessary certifications, and participating in conventions and symposia
Collaborate with others to enhance coordination in promotional efforts
Complete call reporting, updating territory report and expense reports

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Manager - Synthetic & Mammalian Upstream

Exciting Opportunity: Manager - Synthetic & Mammalian Upstream. Are you an exper...

Location

United Kingdom , Darlington

Salary:

50000.00 - 66000.00 GBP / Year

SRG

Expiration Date

Until further notice

Requirements

A degree (or equivalent) in a relevant scientific discipline, with senior‑level research experience
Strong recent expertise in mammalian upstream processing, including CHO and HEK293 systems and bioreactor scale‑up
Strong knowledge of eukaryotic gene design, cloning, and transfection
Experience in synthetic expression technologies, including mRNA synthesis is highly desirable
A proven track record of leading multidisciplinary technical projects and acting as the primary technical contact for clients or stakeholders
Recent leadership experience managing multiple technical specialists
Understanding of GMP principles for biopharmaceutical manufacturing

Job Responsibility

Leading, developing, and empowering a high‑performing scientific team
Providing expert technical direction on complex upstream biologics projects
Overseeing the development and scale‑up of synthetic and mammalian expression systems
Managing project timelines, resources, and cross‑functional coordination
Building external scientific networks and acting as a credible representative of the organisation
Supporting business development activities and contributing to future capability growth

Fulltime

Filtration Sales Specialist

The Filtration Sales Specialist is responsible to support Account Managers with ...

Location

Austria , Kremesmunster

Salary:

Not provided

Danaher Corporation

Expiration Date

Until further notice

Requirements

Experience in technical sales, R&D or production in the biopharmaceutical or similar markets
Bachelor´s Degree or higher in Biotechnology, LifeSciences or relevant field
Self-motivated and used to work independently
Fluency in written and spoken English is a prerequisite
Willingness to travel – >50%, including overnight, within the territory by car and/or plane
Must have a valid driver’s license

Job Responsibility

Primarily focus on Filtration Consumables opportunities and surrounding single use designs within their region, and supports all Filtration Consumables Products and process related single use technologies are sold both by providing the Account Manager in sales process with product expertise as well as independently identifying opportunities
Develop the sales of modality solutions in the assigned sales region/territory, establishing long lasting technical customer relationships
Provide high level technical expertise during pre-sales discussions, instrument demonstrations, customer training, post-sales support, seminars, tenders/quotes, and promotional events
Lead technical and process related discussions with customer Subject Matter Experts and give applicative support including trouble shooting and answer customer queries of sophisticated technical and applicative nature
Develop sales opportunities to create a sales funnel to meet business targets. Manage leads and prospects using customer relationship management software

Fulltime

Qa quality specialist

This position reports to the Associate Director, External Quality, Quality Syste...

Location

Ireland , Cork

Salary:

Not provided

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in science or engineering
Minimum 3+ years of biopharmaceutical experience in a Quality, Compliance, and/or Regulatory setting
Skilled in data analysis and excel
Strong communication and interpersonal skills – Oral, written and presentation skills
Works collaboratively with others to meet shared objectives.

Job Responsibility

Perform the Quality Systems Metric Review for External Quality and oversee relevant metrics and trending for each quality system to proactively drive on-time closure of Quality records
Responsible for managing routine cross-functional meetings to ensure timely closure of Deviations, CAPAs and Change Control, with leadership endorsement
Responsible for development/reporting of metrics and supporting standardization of these across the Organization
Co-ordinate monthly governance site quality review team (SQRT) meeting for GEO / External Quality
Deliver training on Quality Management Systems, as required
Partner with the Global Quality Systems Management Team and other cross functional groups to ensure proper application of the QMS
Identify and implement continuous improvement initiatives to the External Quality systems
Assist as needed in audits and inspections
Participate in development and implementation of global alignment projects with BioMarin’s sister sites
Manage the Self Inspection Programme for External Quality

F&E Technical Services Manager

The F&E Technical Services Manager is a key member of the Site Facilities & Engi...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Science, Engineering, or a related discipline
Significant experience in a cGMP-regulated QC laboratory environment with expertise in laboratory equipment operation, qualification and maintenance
Prior experience leading or supervising technical professionals
Strong knowledge of regulatory expectations for QC laboratory equipment and computerized systems
Understanding of analytical techniques and instrumentation utilized in biopharmaceutical methods and testing
Experience with calibration processes and principles

Job Responsibility

Lead, coach, and develop a team of Technical Specialists
set clear objectives, manage performance, and support succession and capability development
Plan, prioritize, and coordinate team workloads to meet operational demands and project timelines
Promote a culture of technical excellence, compliance, safety, and continuous improvement
Oversee calibration, requalification, and routine maintenance of QC laboratory equipment utilizing the site CMMS system (Maximo/SAP)
Own and govern the qualification lifecycle for new and existing laboratory equipment, including protocol review and approval
Ensure periodic review and ongoing compliance of validated QC equipment and systems
Oversee calibration, requalification, and routine maintenance of Calibration equipment systems and Standards utilizing the site CMMS system (Maximo/SAP)
Represent ADL as the calibration representative within the global metrology network
Support alignment with enterprise standards and contribute to cross‑site improvement initiatives

Packaging & Labeling Artwork Specialist

Colleague fundamentally performs the ePALMS system “Market Coordinator” role in ...

Location

China , Shanghai

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Bachelor’s degree in an appropriate discipline, plus 4-6 years work experience related to Artwork Change Control processes
Must be familiar with Biopharmaceutical Regulatory environment and cGMPs associated with manufacturing, packaging & distribution processes as well as a basic understanding of Artwork & Labeling regulations and controls
Must be able to collaborate with cross-functional Pfizer teams, negotiate across globally distributed affiliates and manufacturing site personnel, and communicate across multiple levels of the organization in a clear professional manner
Solid PC business software skills including document authoring, spreadsheet, database management, and presentation applications are required
Strong written and verbal communication skills required
Strong English language skills are required of non-native English speaking colleague to enable global interactions
Must be able to work under pressure of tight timelines, apply sound judgment in ambiguous business situations, appropriately assess issues for potential impacts and ability to escalate if/as needed
Demonstrate organizational skills
In-depth knowledge of PGS manufacturing and site processes/requirements
Must have capacity to solicit input in ambiguous business situations, resolve conflicting feedback and make appropriate business decisions

Job Responsibility

Initiation and “build” of Pfizer Artwork Requests (PARs) in collaboration with markets, assuring all required information, specifications and/or supportive documentation is available for plants/Artwork Centers to execute the production of product labeling related packaging components
Coordinating Artwork Change Control logistics across multiple Pfizer departments to assure Regulatory timelines for implementation are met and that product supply is not interrupted
Tracking Artwork Key Performance Indicators (KPIs) (e.g. volume, timelines, and/or quality metrics) for assigned projects
Support for large-scale Artwork Change Control projects with broad portfolio impact under the direction of more senior ALIM staff
Research into root cause assessments for internal ALIM Quality Investigations or Area Quality Review Team (AQRT) meetings and potential process improvement recommendations
Retrieve documents and/or generate reports in response to queries from Regulatory Agencies (e.g. inspections) or Assistant General Counsel (e.g. product litigation cases related to labeling in distribution)
Liaises with markets and stakeholders to gather all necessary information to initiate and “build” PARs (according to local or regional requirements) to enable plant production of Labeling Artwork with minimal rework and to meet implementation requirements
May create Editor’s Copy (EC) for select markets depending on language(s) involved and specific “custom” services negotiated with markets in line with local SOPs
Liaises with GRO GLM/IL functions, GRS/PCOs and PGS PCOs, or demand management lines to coordinate any unique factors that need to be considered
documents agreement on Artwork timelines across stakeholders

Fulltime

Senior QA Specialist – Supplier Audits

This role is instrumental in strengthening supplier quality and compliance acros...

Location

United States , California

Salary:

Not provided

Mantell Associates

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Life Sciences, Engineering, Chemistry, or related discipline
Significant experience in supplier quality, audits, and quality systems within a pharmaceutical, biopharmaceutical, or CDMO environment
Strong knowledge of cGMP, ICH, regulatory expectations, and quality risk management principles
Demonstrated ability to lead supplier audits and effectively communicate findings to technical and operational stakeholders
Excellent analytical, report writing, and interpersonal skills with a proactive, solutions-oriented mindset
Ability to travel as required to support supplier audit activities (domestic and, occasionally, international)

Job Responsibility

Plan, execute, and lead supplier audits (on-site and remote) in accordance with cGMP, ISO standards, and internal procedures
Evaluate supplier quality systems, processes, corrective actions, and risk controls to ensure compliance and robust supply continuity
Prepare comprehensive audit reports, findings, and recommendations, and drive closure of audit observations with stakeholders
Support supplier qualification activities, including documentation review, risk assessments, and technical evaluations
Collaborate with Quality, Procurement, Regulatory, and Manufacturing teams to escalate supplier risks and implement mitigation strategies
Maintain audit schedules, quality intelligence, and supplier performance metrics to support continuous improvement
Serve as a subject matter expert on supplier quality expectations, training internal partners as needed

Fulltime

Biopharmaceutical Specialist

Amgen

Location:
Taiwan , Taipei

Category:
Sales

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
December 18, 2025

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