Analytical Specialist - CMC Job at Life Science Talent (Hørsholm)

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

Process Development Senior Scientist - Attribute Sciences

Join Amgen’s Mission of Serving Patients. This is an exciting opportunity to joi...

Location

United States , Cambridge

Salary:

136692.00 - 164965.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree and 5 years of Scientific experience
Master’s degree and 3 years of Scientific experience
Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]
Strong written and verbal communication skills, ability to support data-driven decision making with diverse internal and external stakeholders
5+ years of experience in industrial analytical laboratories supporting characterization of protein therapeutics, including partnering with QC and/or CMOs on method execution
Deep LC/MS expertise in bottom‑up peptide mapping (including disulfide mapping) and intact mass analysis for biologics, with strong fundamentals in sample preparation, artifact control, and MS/MS data interpretation
Hands-on experience with Thermo Orbitrap platforms (e.g., Q-Exactive, Exploris, Tribrids), including routine maintenance, calibration, and independent troubleshooting of common failure modes (sensitivity loss, spray instability, mass accuracy drift, carryover/contamination)
Strong RP‑UHPLC expertise (reversed‑phase method development and troubleshooting) to support peptide mapping/intact workflows (gradient optimization, column selection, carryover mitigation, pressure/peak‑shape troubleshooting)
Hands-on experience with laboratory automation including liquid handlers, pipetting robots, and automation software
Familiarity with United States Pharmacopeia (USP), International Conference on Harmonization (ICH), and Food & Drug Administration (FDA) guidance documents related to analytical method transfer and validation

Job Responsibility

Lead late-stage protein structural elucidation and forced degradation studies using LC/MS workflows including reduced peptide mapping, disulfide mapping, and intact mass analysis
effectively communicate results to support regulatory filings
Maintain, troubleshoot, and optimize high-resolution mass spectrometry methods
partner with instrument vendors and application specialists as needed to ensure reliable performance, consistent data quality, and high instrument uptime
Develop, optimize, and qualify LC/MS and complementary LC-UV protein characterization methods to identify and monitor critical quality attributes
coordinate with program leads to identify and implement control strategies
Lead training, qualification, and method transfer from our process development labs to our global quality network
Interpret analytical results, author and review technical protocols/reports, and contribute to analytical CMC sections in regulatory filing documents including IND and BLAs
Design automation-ready MS workflows including sample preparation, instrument integration, data processing, and report generation to reduce hands-on time and increase lab efficiency
Build robust, inspection-ready LC/MS data analysis and reporting workflows (templates, QC checks, method trending) and ensure traceability and data integrity for CMC deliverables

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

Fulltime

Integrated Care Manager - Adult

Responsible for promoting continuity of care through a collaborative process tha...

Location

United States , Phoenix

Salary:

Not provided

Blue Cross Blue Shield of Arizona

Expiration Date

Until further notice

Requirements

2 year(s) of experience in full-time equivalent of direct clinical care to the consumer
Associate’s Degree in general field of study or Post High School Nursing Diploma or Master’s Degree in a behavioral health field of study (i.e., MSW, MA, MS, M.Ed.), Ph.D. or Psy.D
Active, current, and unrestricted license to practice in the State of Arizona (or an endorsement to work in Arizona) as a behavioral health professional such as LCSW, LPC, LISAC LMFT, or licensed psychologist (Psy.D. or Ph.D.), OR an active, current, and unrestricted license to practice nursing in either the State of Arizona or another state in the United States recognized by the Nursing Licensure Compact (NLC) as an RN
Within 4 years of hire as a Care Manager employee must hold a certification in case management from the following certifications
Certified Case Manager (CCM), Certified Disability Management Specialist (CDMS), Case Management Administrator, Certified (CMAC), Case Management Certified (CMC), Certified Rehabilitation Counselor (CRC), Certified Registered Rehabilitation Counselor (CRRC), Certified Occupational Health Nurse (COHN), Registered Nurse Case Manager (RN, C), or Registered Nurse Case Manager (RN,BC)
Intermediate PC proficiency
Intermediate skill in use of office equipment, including copiers, fax machines, scanner and telephones
Intermediate skill in word processing, spreadsheet, and database software
Maintain confidentiality and privacy
Advanced and current clinical knowledge

Job Responsibility

Assess and collect data related to the member from all care settings. Interview and collaborate with case-related providers, member and family to implement the care plan
Answer a diverse and high volume of health insurance related customer calls on a daily basis
Explain to customers a variety of information concerning the organization’s services, including but not limited to, contract benefits, changes in coverage, eligibility, claims, BCBSAZ programs, provider networks, etc
Analyze medical records and apply medical necessity criteria and benefit plan requirements to determine the appropriateness of benefit requests
Present status reports on all cases to the manager/supervisor and, when indicated, to the medical director
Consult and coordinate with various internal departments, external plans, providers, businesses, and government agencies to obtain information and ensure resolution of customer inquiries
Meet quality, quantity and timeliness standards to achieve individual and department performance goals as defined within the department guidelines
Maintain all standards in consideration of state, federal, BCBSAZ, URAC, and other accreditation requirements
Maintain complete and accurate records per department policy
Demonstrate ability to apply plan policies and procedures effectively

Fulltime

Supervisor, Medical Coding

The Assistant Coding Manager serves as a key support leader within the assigned ...

Location

United States of America , Rochester

Salary:

60431.00 - 84603.00 USD / Year

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelor's degree and 2 years of coding experience required, or equivalent combination of education and experience
Knowledge of ICD-10-CM, CPT and HCPCS required
Working knowledge of medical terminology and anatomy required
Certification in one of the following: RHIA - Registered Health Information Administrator Successful completion of American Health Information Management Association (AHIMA) accreditation examination upon hire required or RHIT - Registered Health Information Technician upon hire required or CCS-Certified Coding Specialist upon hire required or Certified Professional Coder (CPC) from American Academy of Professional Coders upon hire required or Certified Medical Coder (CMC) from the Practice upon hire required

Job Responsibility

Provides assistance to the Manager by driving revenue cycle results through effective oversight of activities that impact professional charging and receivables
Ensures proper training and supervision of assigned staff members, while implementing and upholding URMFG best practice standards
May prepare reports and analyze data for presentation purposes
Acts as a subject matter expert on team functions and underlying processes
Uses knowledge and experience to review and trend analytic and reporting data identifying problem areas and directing actions to resolve deficiencies
Provides first-line management of assigned teams
Provides supervision, leadership, coaching and counseling
Ensures hands-on training is provided to assigned team
May serve as department liaison on matters related to business functions

Fulltime

Drug Substance Senior Specialist – Biologics

We are seeking a Drug Substance Senior Specialist with strong experience in biol...

Location

Denmark , København og omegn

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Master’s degree in biotechnology, chemical engineering, pharmaceutical sciences, or related field
8+ years of industry experience in biologics process development and validation, including collaboration with CDMOs
Proven experience with PPQ and process characterization for antibody drug substances
Solid understanding of ICH Q8–Q11 and global validation expectations
Practical knowledge of commercial-scale GMP operations, tech transfer, and regulatory submissions
Experience in early-stage process development and scale-up
Strong project management and organizational abilities
Excellent communication and technical writing skills for regulatory documentation
Collaborative mindset and ability to work effectively with external partners
Flexible, proactive, and comfortable operating in a fast-paced biotech environment

Job Responsibility

Support early-stage antibody programs by applying phase-appropriate development strategies
Collaborate with Quality, Regulatory, and Analytical teams to align on validation approaches
Provide technical input to CDMOs on process design, scale-up, and risk assessments
Plan and manage process performance qualification (PPQ) and characterization studies in partnership with CDMOs
Define and document CPPs, CQAs, and control strategies based on risk and data-driven insights
Ensure validation documentation (protocols, reports, summaries) complies with ICH Q8–Q11, FDA, and EMA expectations
Support implementation of continuous process verification (CPV) and lifecycle validation strategies
Oversee technology transfer to external manufacturing partners for commercial readiness
Contribute to CMC regulatory submissions (BLA/MAA) focusing on validation and control strategy
Coordinate comparability studies and process optimization activities with CDMOs

Fulltime

New

Administrator

An up and coming business are growing, and they’re looking for their first Admin...

Location

United Kingdom , Manchester

Salary:

26000.00 - 27000.00 GBP / Year

Platinum Recruitment Group Ltd

Expiration Date

Until further notice

Requirements

6-12 months administration experience
Completed an apprenticeship in business administration

Job Responsibility

Liaising with clients
Supporting with director diary management and meetings
Data management on the system
Supporting the team with documentation
Office management support

What we offer

Lunches
Friday beers
Mentorship and training
Young and dynamic business culture
Small community
Supportive team

Fulltime

New

Operations Manager

We’re building a world of health around every individual — shaping a more connec...

Location

United States , Fresno

Salary:

21.90 - 35.90 USD / Hour

CVS Health

Expiration Date

April 24, 2026

Requirements

Deductive reasoning ability
Advanced analytical skills
Computer skills
Advanced communication skills
Leadership skills
Supervision skills
Influencing skill
Ability to work a full-time flexible schedule, including some early morning, overnight and weekend shifts
Ability to work overtime as needed
Ability to respond to urgent issues at the store when they arise

Job Responsibility

Overall store management, supervision, and policy implementation
Sales and inventory management
Employee staffing, training, and development
Financial management
Customer service leadership
Lead others and work effectively with store crews
Supervise, assign and direct activities of the store’s crew
Effectively communicate information to store crew and supervisors
Support Store Manager with actions plans for operational and service improvement
Assist customers with their questions, problems and complaints

What we offer

Affordable medical plan options
401(k) plan with matching company contributions
Employee stock purchase plan
Wellness screenings
Tobacco cessation programs
Weight management programs
Confidential counseling
Financial coaching
Paid time off
Flexible work schedules

Parttime

New

Speech Language Pathologist

Aegis Therapies, one of the nation’s leading providers of rehabilitation and wel...

Location

United States , Derby

Salary:

Not provided

Aegis Therapies

Expiration Date

Until further notice

Requirements

Current license as a Speech Language Pathologist or ability to obtain in the state of practice

What we offer

Support, local clinical mentorship, clinical education and unlimited CEUs
Create your own career path: clinically, management, etc.
Flexible schedule, paid time off, plus one paid CEU day
Licensure and professional membership reimbursement
Interdisciplinary collaboration for providing the best patient care
Medical, dental, vision within 30 days or less
National opportunity to transfer while maintaining employment status
Multiple settings nationwide: CCRC, SNF, Independent Living, Assisted Living, Outpatient Clinics, Home Health, Telehealth, Post-Acute

Fulltime

Analytical Specialist - CMC

Life Science Talent

Location:
Denmark , Hørsholm

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
February 17, 2026

Expiration:
March 08, 2026

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Location:
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Category:
Research and Development

Contract Type:
Not provided

Job Posted:
February 17, 2026

Expiration:
March 08, 2026