CrawlJobs Logo
Life Science Talent Logo Life Science Talent · Research and Development

Drug Substance Senior Specialist – Biologics

Denmark, København og omegn · Job Posted January 05, 2026
Apply Position
Job Link Share

Job Description

We are seeking a Drug Substance Senior Specialist with strong experience in biologics process development and validation. You will play a key role in driving process characterization, validation, and technology transfer for antibody programs in close collaboration with our CDMOs. This position spans both early- and late-stage development, ensuring smooth progression from clinical manufacturing to commercial readiness.

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
  • Monitor regulatory trends and integrate new validation approaches
  • Identify and execute opportunities for process optimization and cost reduction
  • Share best practices and mentor colleagues in validation science

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
Life Science Talent - All Job Offers

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Drug Substance Senior Specialist – Biologics

8 matching positions

New

Assistant Manager Store

Location
Location
United States , Taos
Salary
Salary:
Not provided
iaggbs.com Logo
IAG GBS
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum 18 years old
  • Reliable transportation to and from work
  • Full-Time work availability
  • Previous management and/or quick service restaurant experience is a plus!
  • Be able to work with minimal supervision
  • Be able to motivate and build solid, cohesive teams
  • Have strong communication and problem-solving skills
Job Responsibility
Job Responsibility
  • Provide managerial assistance to the store's General Manager in running and implementing operating standards
  • Counting inventory and supplies
  • Ensure facility and equipment cleanliness based on company standards
  • Efficient employee supervision
  • Interviewing, hiring, and onboarding new team members
  • Cleaning and maintenance of the store and its equipment
  • Rotating commissary deliveries
  • Other job duties, as needed
What we offer
What we offer
  • Bonus Potential
  • Paid Time Off
  • Medical & Dental Insurance
  • 401K
  • Employee Discount
  • Advancement opportunities
  • Fulltime
Read More
Arrow Right
New

Sr AI Engineer

As a Sr AI Engineer on the IntentCX team, you will drive the optimization and or...
Location
Location
United States , Bellevue
Salary
Salary:
133100.00 - 240100.00 USD / Year
https://www.t-mobile.com Logo
T-Mobile
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 4+ yrs developing and deploying machine learning models, particularly in the context of AI-driven customer service automation
  • 4+ yrs experience with advanced AI techniques such as prompt engineering, fine-tuning, and creating AI tools and workflows
  • 4+ collaborating with cross-functional teams to integrate AI systems into production environments
  • Proficiency in Python and AI development frameworks for building scalable AI applications
  • Experience with operational excellence practices and observability tools (e.g., Weights & Biases, Splunk, Datadog) for monitoring, logging, and troubleshooting AI systems in production
  • Experience with project management tools and agile methodologies (e.g., Jira, Azure DevOps) to plan, track, and deliver AI initiatives efficiently in cross-functional environments
  • Experience in LLM fine-tuning and prompt engineering (e.g., OpenAI APIs, Hugging Face, Anthropic Claude, Google Gemini)
  • Experience with AI orchestration tools (e.g., LangChain, LlamaIndex, vector databases for retrieval augmented genetation)
  • Hands-on knowledge of function calling and API-based reasoning models (e.g., using structured outputs to drive automated workflows)
  • Familiarity with RAG pipelines and vector database retrieval for augmenting AI responses
Job Responsibility
Job Responsibility
  • Builds agentic AI systems that accomplish complex tasks by invoking AI models as well as internal and third-party tools using APIs, ensuring seamless data flow in production environments
  • Optimizes performance of agentic AI systems through innovative techniques such as prompt engineering, fine-tuning and reinforcement learning using T-Mobile’s customer interaction data
  • Develops AI tools, workflows, and middleware to enhance model capabilities, such as structured reasoning, multi-step task execution, and improved contextual memory
  • Implements retrieval-augmented generation (RAG) techniques to ensure AI responses are contextually accurate and grounded in real-time data
  • Collaborates in a highly matrixed environment with backend engineers, business experts and conversation designers to ensure AI-driven enhancements are effectively integrated into production environments
  • Tracks success metrics that aligns with business requirements and continuously evaluate and improve model quality based on those metrics
  • Develops internal tooling and automation to streamline AI deployment, evaluation, and self-improvement mechanisms
  • Monitors real-world AI performance and proactively iterates on model behavior based on live interaction data
  • Stays up-to-date with latest LLM advancements in prompt design, prompt optimization, few-shot learning, Tool integration protocols like MCP and AI orchestration frameworks like Agent SDK
What we offer
What we offer
  • competitive base salary
  • annual stock grant
  • employee stock purchase plan
  • 401(k)
  • free year-round money coaches
  • medical insurance
  • dental insurance
  • vision insurance
  • flexible spending account
  • paid time off
  • Fulltime
Read More
Arrow Right
New

Specialist, Broadband

This role is essential for expanding the customer base through direct community ...
Location
Location
United States , Various
Salary
Salary:
30000.00 - 48600.00 USD / Year
https://www.t-mobile.com Logo
T-Mobile
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High School Diploma/GED (Required)
  • Less than 2 years - Engaging with customers in a direct sales or retail environment, particularly in telecommunications or consumer electronics
  • Less than 2 years - Presenting and explaining complex product offerings effectively to potential customers
  • Less than 2 years - Working in a target-driven sales role, with a proven track record of meeting or exceeding sales targets
  • Sales Proficiency in direct consumer sales, with a focus on door-to-door sales tactics to effectively engage and expand the customer base. (Required)
  • Communication Exceptional verbal and effective written communication skills necessary for articulating T-Mobile's offers clearly and interacting persuasively with potential customers. (Required)
  • Customer Engagement Strong ability to connect with customers, address their inquiries, and facilitate a seamless integration into T-Mobile services, enhancing customer satisfaction and loyalty. (Required)
  • Negotiation Advanced negotiation capabilities to secure sales agreements and achieve or exceed set sales targets. (Required)
  • Problem Solving Competence in identifying and resolving issues during the sales process, ensuring a smooth customer experience. (Required)
  • Adaptability Flexibility to modify sales approaches based on varying customer needs and evolving market conditions, maintaining effectiveness across scenarios. (Required)
Job Responsibility
Job Responsibility
  • Drive customer acquisition by engaging potential customers through door-to-door and community outreach activities to present broadband service offers
  • Conduct post-sale follow-up interactions to support customer satisfaction and service retention
  • Manage communication of service benefits and address customer inquiries to facilitate informed decisions
  • Collaborate with sales leadership to align outreach efforts with business objectives and market strategies
  • Also responsible for other duties/projects as assigned by business management as needed
What we offer
What we offer
  • Annual stock grant
  • Employee stock purchase plan
  • 401(k)
  • Free money coaches
  • Medical, dental and vision insurance
  • Flexible spending account
  • Paid time off
  • Paid holidays (about 4 weeks for new full-time employees and about 2.5 weeks for new part-time employees annually)
  • Paid parental and family leave
  • Family building benefits
  • Fulltime
Read More
Arrow Right
New

Assistant Manager Store

Location
Location
United States , Kirtland AFB
Salary
Salary:
Not provided
iaggbs.com Logo
IAG GBS
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum 18 years old
  • Reliable transportation to and from work
  • Full-Time work availability
  • Previous management and/or quick service restaurant experience is a plus
  • Be able to work with minimal supervision
  • Be able to motivate and build solid, cohesive teams
  • Have strong communication and problem-solving skills
Job Responsibility
Job Responsibility
  • Provide managerial assistance to the store's General Manager in running and implementing operating standards
  • Counting inventory and supplies
  • Ensure facility and equipment cleanliness based on company standards
  • Efficient employee supervision
  • Interviewing, hiring, and onboarding new team members
  • Cleaning and maintenance of the store and its equipment
  • Rotating commissary deliveries
  • Other job duties, as needed
What we offer
What we offer
  • Bonus Potential
  • Paid Time Off
  • Medical & Dental Insurance
  • 401K
  • Employee Discount
  • Advancement opportunities
  • Fulltime
Read More
Arrow Right
New

Registered Nurse – Outpatient (Bank)

The Runnymede Hospital in Chertsey is part of Circle Health Group, Britain's lea...
Location
Location
United Kingdom , Chertsey
Salary
Salary:
20.00 GBP / Hour
circlehealthgroup.co.uk Logo
Circle Health Group
Expiration Date
June 28, 2026
Flip Icon
Requirements
Requirements
  • Registered Nurse (Adult) with valid NMC registration
  • Demonstrable experience working in a clinical healthcare setting
  • Good understanding of clinical governance, patient safety, and evidence-based practice
  • Excellent communication and interpersonal skills
  • Ability to work effectively both independently and as part of a multidisciplinary team
  • Proficient in IT systems used for patient records, documentation, and care planning
  • Previous experience in a relevant specialty desirable (e.g., surgical, medical, outpatient, orthopaedics, critical care)
Job Responsibility
Job Responsibility
  • Deliver direct nursing care in line with patient care plans and clinical protocols
  • Assess patient needs, prioritise care, and update care plans accordingly
  • Monitor vital signs, recognise changes in condition, and escalate appropriately using clinical judgement
  • Administer medications safely and effectively in accordance with hospital policies and the NMC Code
  • Maintain accurate, legible, and timely nursing documentation, including assessments, care plans, and observations
  • Ensure that all care provided complies with NMC standards, clinical governance requirements, and hospital policies
  • Identify and report incidents, safeguarding concerns, and potential risks in line with hospital procedures
  • Parttime
Read More
Arrow Right
New

General Manager

Domino's Team BAM! is looking for a talented General Manager with proven restaur...
Location
Location
United States , Atlanta
Salary
Salary:
Not provided
iaggbs.com Logo
IAG GBS
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Prior experience in a management role or similar experience (required)
  • Customer Service experience (required)
  • Fast food/quick service restaurant experience (preferred)
  • Valid driver's license (required)
  • High School education or equivalent
  • Ability to lead by example and ensure accountability from a team
  • Problem-solving, Decision-making, & Conflict-resolution skills
  • Ability to work as a part of a team to achieve a common goal
  • Experience managing a P&L, food cost, and labor
  • Ability to add, subtract, multiply, and divide accurately and quickly
Job Responsibility
Job Responsibility
  • Manage Store Operations and Drive Results - Including, but not limited to: cost controls, inventory, food, image standards, store cleanliness, attendance & punctuality
  • Recruit, Develop, and Retain staff team members
  • Manage Food Safety and Team Member Safety
  • Provide Best in Class Customer Service
  • Increase Sales and Profit Potential
What we offer
What we offer
  • Competitive Base Salary
  • Bonus Potential
  • Paid Time Off
  • Medical & Dental Insurance
  • Vision Insurance
  • 401K
  • Advancement opportunities
  • Fulltime
Read More
Arrow Right
New

Senior Software Engineer - Python

Rapid7 is a publicly traded Cybersecurity company headquartered in Boston, MA wi...
Location
Location
India , Pune
Salary
Salary:
Not provided
rapid7.com Logo
Rapid7
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • A minimum of 5+ years experience in software development, with deep expertise in Python, Core Java and object-oriented programming (OOP) principles
  • Ability to work in Python APIs, FastAPI, Django and experience using Core Java libraries and features (e.g., Concurrency, Collections, I/O). proven ability to quickly learn and contribute in Python development for scripting, tooling, or service implementation
  • Expertise with Core Java features, data structures, and advanced libraries (e.g., NIO, advanced concurrency primitives, and diagnostic tools)
  • Solid experience with dependency management (Maven/Gradle) and testing frameworks (JUnit/TestNG)
  • Experience with CI/CD pipelines (Jenkins, GitLab CI, etc.) and proficiency with version control systems (GitHub/GitLab)
  • Excellent collaboration and communication skills, with the ability to articulate technical designs and tradeoffs to both technical and non-technical audiences
  • Mentors teammates in effective use of Copilot/LLM-driven development practices, improving overall team productivity
  • Designs safe, robust, and testable GenAI-powered features
  • A passion for mentoring, driving technical excellence, and continuous improvement
Job Responsibility
Job Responsibility
  • Lead the design, development, and delivery of complex, high-impact features and services, ensuring they are scalable, highly available, and secure
  • Act as a subject matter expert for the team's core services, driving Core Java best practices and enforcing high code quality standards
  • Mentor and coach junior and mid-level engineers on technical design, implementation, and Core Java development standards
  • Collaborate with other Senior Engineers and Architects to define technical solutions and interfaces across multiple services
  • Conduct thorough code reviews and contributing to improving engineering processes, CI/CD pipelines, and operational excellence
  • Drive the resolution of complex production issues, performing root cause analysis, and implementing preventative measures
Read More
Arrow Right
New

Senior Product Manager

As a Senior Product Manager for Exposure Management, you will own one or more cr...
Location
Location
India , Pune
Salary
Salary:
Not provided
rapid7.com Logo
Rapid7
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 2–3+ years of experience in the vulnerability management / exposure management space, such as vulnerability management platforms, risk-based prioritization, or attack surface management
  • Professional experience in cybersecurity, ideally building or supporting security products or working closely with security / IT teams
  • Proven experience as a Product Manager shipping B2B SaaS products in complex, technical domains
  • Demonstrated ability to own the end-to-end product lifecycle – from opportunity assessment and discovery through launch, iteration, and sunset
  • Track record of making data-informed decisions, using product analytics, customer feedback, and business metrics to drive prioritization and measure impact
  • Experience working closely with engineering and UX/design to translate ideas and low-/high-fidelity concepts into intuitive, outcome-driven product experiences
  • Strong customer-centric mindset, with experience engaging directly with customers to uncover unmet needs and turn insights into roadmap and strategy
  • Proven cross-functional leadership skills, aligning engineering, UX, GTM, customer success, and threat research (or similar functions) around shared goals and outcomes
  • Demonstrated stakeholder management and influence, including securing buy-in from senior leaders and communicating trade-offs clearly
  • Experience mentoring or coaching other PMs or cross-functional partners, and contributing to a culture of continuous improvement
Job Responsibility
Job Responsibility
  • Own end-to-end product delivery, translating complex requirements into prioritized specs
  • Own the company-aligned product vision and near-term roadmap, making principled trade-offs to avoid diminishing returns and maximize long-term value
  • Engage customers to uncover unmet needs and turn insights into strategy
  • Drive cross-functional alignment across Engineering, UX, GTM, Customer Success, and Threat Research
  • Mentor and elevate junior PMs to strengthen execution and strategic thinking
  • Fulltime
Read More
Arrow Right