Bioengineer Job at KGTiger

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Program Manager Pharmaceuticals

Job Purpose: Within the External Manufacturing you will support Contract Manufac...

Location

Belgium , Wavre

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

University degree with a scientific orientation (Bioengineering, Biology, Biotechnology, Pharmacology, Chemistry) or equivalent experience
5 years of experience in a GMP/cGMP environment (pharma, biotech, or similar regulated industry)
Strong knowledge of GMP and regulatory requirements
Experience in quality assurance activities: deviations, CAPA, change control, complaints management
Experience in lean management, continuous improvement, and governance of processes
Not a hands-on technical lab/production role – focus on process, governance, and QA oversight
Knowledge of SAP and VEEVA is a strong asset
Analytical and critical mindset, with a global and pragmatic approach
Strong problem-solving skills
Good impact and influence capabilities and networking skills to work efficiently within QA, IT, and other operational departments in a matrix organization

Job Responsibility

CMO Quality Oversight & Governance: Take accountability for main quality activities related to CMO management
Review and follow up on deviations, ensuring appropriate investigation and documentation
Monitor and support CAPA implementation and timely closure
Manage and assess change controls linked to CMOs and their impact on product quality
Help put in place and maintain governance for quality processes and interactions with CMOs
Batch Release & Complaints: Provide support for product batch release activities (documentation review, quality decision support)
Ensure the review and approval of product market complaints related to externally manufactured products
Contribute to root cause analysis and definition of corrective and preventive actions
Lean Management & Continuous Improvement: Drive or support continuous improvement initiatives within EM Q DP and across QA/IT matrix teams
Apply lean management principles to streamline quality processes and improve efficiency

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

Dmpk Modeller

You will join a DMPK drug discovery team in Spain to influence how we translate ...

Location

Spain , Madrid

Salary:

60525.00 - 100875.00 EUR / Year

GSK

Expiration Date

Until further notice

Requirements

Degree in Pharmacology, Pharmaceutics, Pharmacokinetics, Mathematics, Bioengineering, or a related discipline
Practical experience in population PK, PBPK, or mechanistic PK/PD modelling in a biopharma setting
Hands-on experience with modelling software such as, Matlab (symbiology), Monolix, Simcyp, GastroPlus, or equivalent
Experience translating in vitro and preclinical data to humans
Strong written and verbal communication skills in English
ability to explain modelling outcomes to non-specialists
Experience working in cross-functional project teams

Job Responsibility

Lead development and application of pharmacokinetic and pharmacokinetic-pharmacodynamic (PK/PD) models for small molecules and other modalities to inform project decisions
Design and deliver translational modelling strategies, including dose prediction and human exposure projections
Assess and quantify drug-drug interaction (DDI) risk using in vitro-in vivo translation and modelling approaches
Communicate model assumptions, results and uncertainty clearly to cross-functional teams and governance bodies
Mentor and coach colleagues on modelling methods, good practices and scientific interpretation
Contribute to regulatory and internal documents with clear, evidence-based modelling narratives

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes

Fulltime

Senior Machine Learning Engineer

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

Location

United States , Thousand Oaks

Salary:

158606.00 - 200052.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree (or foreign equivalent) in Computer Science, Statistics, Electrical Engineering, Mathematics, Bioengineering or a related field and 4 years of experience in the job offered or in a Data Scientist related – Occupation
4 years of experience in the following: 1) Programming skills in Python including experience with scientific computing and machine learning libraries including pandas, NumPy, scikit-learn, XGBoost, LightGBM, TensorFlow and PyTorch
2) Applying supervised and unsupervised learning techniques to real-world problems, including experience with Random Forest, XGBoost, ensemble models, and deep learning architectures
3) Version control (Git), containerization and orchestration tools including Docker and Kubernetes, and cloud environments including AWS or GCP
4) Involved with data science platforms including Databricks and SageMaker
5) Using statistical methods industry including regression modeling, hypothesis testing, Bayesian methods, Forecasting techniques and time-series analysis
6) Building ETL (Extract, Transform, Load) pipelines for handling large-scale, high-dimensional datasets, familiarity with healthcare data structures and data types
7) Experience with software DevOps CI/CD tools and GitLab
8) Experience developing and fine-tuning Natural Language Processing (NLP) models, including work with architectures such as BERT, ALBERT, GPT, and other transformer-based models.

Job Responsibility

Lead efforts with Amgen business leaders to identify, explore and develop transformative AI and ML solutions to enable access to computational tools and data within Amgen, and ultimately improve patient outcomes across multiple therapeutic areas
Utilize Cloud Services to collect, store, preprocess, and analyze large datasets from various sources across Amgen
Collaborate with other ML engineers, data scientists and research scientists to identify appropriate ML models and algorithms
Facilitate ML & Data engineering efforts by architecting and guiding the implementation of data and ML pipelines for development and deployment
Facilitate model deployment to production, including monitoring and maintenance of ML models, put in place metrics to assess accuracy and drift
Define model evaluation and validation strategies, train and test models, and analyze and resolve errors and biases in models
Lead and develop standards, processes, and best practices for the team across the machine learning-based solution implementation lifecycle
Involved in technical guide and career development mentor to junior machine learning engineers and data scientists in a formal or matrixed fashion.

What we offer

stock
retirement
medical
life and disability insurance
eligibility for an annual bonus or for sales roles, other incentive compensation
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

Fulltime

Process Development Sr Associate

Support the development, characterization and scale up of cell culture and prote...

Location

United States , Thousand Oaks

Salary:

96605.00 - 119055.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Master's Degree in Biotechnology, Bioengineering, Microbiology or related field and completion of a university-level course, research project, internship, thesis, or one year of experience in the following: Cell culture principles, cell metabolism profiles, protein chromatography, filtration and UF/DF operations to perform small scale bioprocess experiments that encompass both upstream (cell culture) and downstream (purification) operations
Experience with mammalian cell culture to maintain and scale up cell culture in shake flasks, culture bags and bench top bioreactors
Experience with purification operations to run bench-top chromatography columns to generate purified antibody product
Identify and solve problems by applying scientific and engineering principles
Design of experiments and statistical analysis of data and programming in JMP, R, or Python environments
Experience with automation efforts to enable high throughput technologies for accelerated process development

Job Responsibility

Support the development, characterization and scale up of cell culture and protein purification operations to enable commercial manufacturing advancement by conducting experiments, analyzing data, and documenting results
Work closely with senior scientists and engineers to implement process improvements
Support development of early phase cell culture, recovery and purification processes for Amgen's large molecule expansion through production bioreactor, harvest, clarification, chromatography, and/or filtration technologies as well as completing virus clearance studies
Identify, develop and implement solutions to practical problems through application of fundamental scientific and engineering principles

What we offer

stock
retirement
medical insurance
life insurance
disability insurance
eligibility for an annual bonus
health and welfare plans
financial plans with opportunities to save towards retirement or other goals
work/life balance
career development opportunities

Fulltime

Field Application Scientist – Cell Therapy/Gene Delivery

Manage customer interactions, both pre-sales technology presentations and post-s...

Location

United States; Germany; Switzerland , Boston; Germany; Switzerland

Salary:

Not provided

AchieveBio

Expiration Date

Until further notice

Requirements

Advanced degree (M.S. or Ph.D.) in Immunology, Cell Biology, Bioengineering, or similar
FAS experience supporting cell therapy or genome editing workflows
Experience with ex-vivo culture and genetic manipulation of primary immune cells
Understanding of current genome editing technologies
Excellent interpersonal, communication and presentation skills
Comfortable working in a collaborative, fast-paced environment
Self-motivated and results-oriented
Able to travel up to 70%

Job Responsibility

Lead the experimental design and execution of product demonstrations at customer sites
Support integration of the technology platform into existing customer workflows
Partner closely with customers to optimize transfection parameters and improve experimental outcomes
Provide high-level technical and troubleshooting support by diagnosing issues and recommending solutions
Partner with Business Development to increase technology adoption in key accounts
Represent the company at trade shows, vendor events, and scientific conferences through presentations and customer engagement

What we offer

Competitive salary, plus equity and excellent benefits

Fulltime

Clinical Trial Supply Manager

Alsinova is looking for a Clinical Trial Supply Manager to join our consulting t...

Location

Belgium , Brussels

Salary:

Not provided

Astek

Expiration Date

Until further notice

Requirements

Master's degree in Biology, Biochemistry, Chemical Engineering, Bioengineering, Pharmacy, or other relevant discipline
At least 3 years of experience in a Clinical Supply Manager role or any other related responsibilities
Fluent in written and spoken English
Excellent coordination skills
Strong and overall clinical Project/Study knowledge
Familiar with Good Clinical Practices (GCP) & Good Distribution Practices (GDP) quality standards
Knowledgeable about Clinical Trial Supplies Operations (Labelling/Pack/Warehouse/Distribution)
Ability to maintain accurate records and files in accordance with cGMPs and SOPs
Ability to independently perform trouble-shooting and problem-solving
Strong leadership, communication and interface management skills

Job Responsibility

Translation of study protocols into operational demand
Feasibility assessment for completion of logistical activities
Definition of logistical operational strategies (supply, distribution, randomization)
Set-up and follow-up of clinical supply related activities for a project or a group of studies
Guaranty of alignment among the network of stakeholders, Good Manufacturing Practices (GMP) operations and clinical operations (central and local) to support the delivery of clinical vaccines and ancillaries in time at right quality and within agreed budget

What we offer

Attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization)
Training (technical and non-technical courses)
Friendly and inclusive work environment

Fulltime

Process Development Senior Associate

At Amgen, if you feel like you’re part of something bigger, it’s because you are...

Location

United States , Cambridge

Salary:

85306.00 - 103484.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree or (foreign equivalent) in Chemical Engineering, Bioengineering, Analytical Chemistry, Biochemistry or a related field & completion of a university-level course, research project, internship, thesis, or one year of experience in the following: 1. Analytical chemistry experience for small molecules, and completion of project deliverables including: designing and conducting targeted metabolomics experiments, extracting and analyzing results via dedicated software: ChemStation, MassHunter, or MassAnalyzer
2. Analytical method development (chromatography and mass spectrometry), related technologies and instrumentation including: U/HPLC, GC, or LC-MS
3. Method qualification and transfer for analytical instruments, along with data analysis and statistical evaluation of experimental results
4. Application analytical instrument troubleshooting across different platforms: Waters, Agilent, or Sciex, and problem solving of such technologies
5. Implementing Standard Operating Procedures in a laboratory environment in accordance with GLP standards
and 6. Maintaining a laboratory notebook.

Job Responsibility

Conduct experiments, analyze results, and implement process improvements to enhance efficiency and product quality
Design, develop, and optimize manufacturing processes
Collaborate closely with a team of analysts and scientists
Responsible for the technical aspects of developing analytical tools to gain understanding of quality attributes in product and process for late phase synthetic small molecule, synthetic peptide, and siRNA programs
Utilize platform and in-depth product attribute knowledge to advance Amgen products and ensure success through pivotal clinical phases to marketing authorization application
Develop, optimize, and execute analytical methods for synthetic small molecules, synthetic peptide, and SiRNA release testing and process characterization
Collaborate closely with drug substance process development team to achieve project objectives and provide analytical data to support drug substance product development.

What we offer

stock
retirement
medical
life and disability insurance
eligibility for an annual bonus
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

Fulltime

Biomedical Engineer (Regional Clinical Specialist)

Provide on-site consulting and guidance to physicians and Operating Room (OR) pe...

Location

United States , Chicago

Salary:

65000.00 - 80000.00 USD / Year

Brainlab

Expiration Date

Until further notice

Requirements

B.S. in Biomedical Engineering, Biomechanical Engineering, Bioengineering, Clinical Engineering, or Nursing required
1-3 years minimum experience in a technical support role preferably for a healthcare company or Provider
1-2 years minimum sales experience with healthcare company preferred
Knowledge of surgical procedures, anatomy and medical terminology preferred
Proficient in the use of PC software applications including Microsoft Office
Self-motivated, detail oriented and a proven history of ability to make independent decisions

Job Responsibility

Provide on-site consulting and guidance to physicians and Operating Room (OR) personnel by evaluating options and problem-solving during surgery in order to maximize Brainlab product efficiency and usage
Manage and maintain install base, including basic 3rd Party integrations
Analyze and resolve product issues for Brainlab systems at assigned Account(s) via Salesforce through detailed analysis and utilization of critical thinking via technical training and documentation
Utilize engineering expertise to contribute to the quality improvement process by recommending product modifications
Provide clinical case coverage & support for Complex Cases and Go Live launches (based on availability)
Manage the process of driving customer utilization, especially via unique workflows and special applications
Act as escalation point for clinical regional issues
Direct and assist Radiology staff in performing necessary scans prior to surgery
Educate/train physicians and hospital personnel, including OR staff, Radiology, Central Sterile Processing, Biomedical and Information Technologies staff, on the use of Image Guided Surgery (IGS) products and services
Develop and conduct training programs for hospital staff enabling them to implement in-house training

What we offer

business casual environment
competitive compensation package including medical, dental, life, LTD, STD, and matching 401k benefits and much more

Fulltime

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Bioengineer

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Looking for more opportunities?

Bioengineer

Program Manager Pharmaceuticals

Dmpk Modeller

Senior Machine Learning Engineer

Process Development Sr Associate

Field Application Scientist – Cell Therapy/Gene Delivery

Clinical Trial Supply Manager

Process Development Senior Associate

Biomedical Engineer (Regional Clinical Specialist)

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