GMP Operations Sr. Scientist (Cell Culture)
Role: GMP Operations Senior Scientist (Cell Culture) About the Company: The biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that we work with is committed to taking innovative gene treatments from concept to market. Situated in the center of Columbus, Ohio, the business has grown to occupy three buildings totaling over 250,000 square feet. This company is responsible for preclinical non-cGMP activities, and is devoted to cGMP manufacturing, and researching cGMP plasmid manufacturing. Responsibilities: Ensure top performance from the production staff. Be a collaborative, guiding, and influencing member of the production team. Assign work to production workers to guarantee that client and corporate deliverables are completed on time and with the right metrics. Carry out the scaling up of adherent and suspension cell lines to facilitate continuous large-scale manufacturing. Address all concerns, troubleshoot production problems, and offer possible solutions to sustain productive production activities. Assist the supply chain in material requisitioning and disposal. To meet production objectives, make sure material deadlines are fulfilled. Develop, oversee, and oversee the implementation of change requests (CR) and corrective and preventative actions (CAPA) required to guarantee that production modifications and enhancements are carried out on schedule. Oversee all facets of the client batch record requirements and production paperwork, following the established GDP standards. What you can expect when working at this company The pride of contributing to the development and manufacturing of life-saving therapies. The invaluable experience of being a part of building the foundation of a new organization. The opportunity to work alongside experts who have over 10 years in the gene therapy field. Competitive compensation Eligible on day one for medical, dental, and vision insurance plans with basic vision at 100% company-paid 160 hours of Paid Time Off annually 11 Company Paid Holidays plus 2 floating holidays annually. Company Paid Life Insurance 401(k) Match Company Paid short and long-term disability. 4 weeks of Paid Parental Leave for birth and adoption Adoption Assistance Tuition Reimbursement and Student Loan Repayment Assistance Company Paid LinkedIn Learning access. Employee Assistance Programs Flexible work options (role specific)
US$80000 - US$95000 per year
Columbus
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Principal Scientist - Drug Substance
Principal Scientist - Drug Substance, Process Development Greater Los Angeles Area Salary: $120,000 - $130,000 + bonus + excellent benefits (local candidates preferred) A growing pharmaceutical company is looking to hire a Principal Scientist focused on Drug Substance and Process Development for their Cell Culture and Purification manufacturing processes. This is a growth hire due to recent expansion plans and success of current clinical pipeline. This person will work alongside the Manufacturing Sciences department and will be responsible for overseeing day to day manufacturing support, global process alignment/improvements, and initiatives of commercial and clinical manufacturing operations of a multi-product manufacturing plant. This pharmaceutical company is one of few players in this space that has a strong clinical and commercial pipeline of products that are manufacturing and are looking to manufacture. This opportunity allows for extremely fast career progression potential with the chance of being one of the leaders in terms of the strategic direction of the team. Responsibilities: Lead and coordinate technical and cross-functional teams in technology transfer, process optimization, and investigative tasks. Manage and oversee Quality by Design activities and documentation, including process FMEAs and risk assessments. Develop, review, and implement study and validation protocols and reports. Serve as a Subject Matter Expert in manufacturing investigations and process performance monitoring (Lifecycle Process Validation Stage 3 Continuous Process Verification), ensuring quality, yield, capacity, and timelines are met, while troubleshooting GMP equipment and processes and providing technical input for SOPs and production records. Partner with global counterparts to support shared initiatives and strategies. Contribute to and manage, when necessary, Validation Master Plans, Process Validation, and Material Qualification activities for capital projects, process improvements, technology transfers, and material changes. Function as a subject matter expert for audits, change controls, and regulatory submissions. Requirements: Bachelor's degree in scientific field or related with at least 10 years of relevant experience, MS with at least 8 years, or Ph.D. with at least 4 years of relevant experience. Extensive knowledge in cell culture, purification, process scale-up, troubleshooting, and technical evaluations of processes, with strong skills in statistical analysis and experimental design. Comprehensive understanding of laboratory and pharmaceutical production equipment, including bioreactors, chromatography, ultrafiltration, diafiltration, sterile filtration, process tanks, and CIP/SIP systems. Skilled in conducting Product Impact Assessments to support process deviations. Expertise in generating risk assessments for change controls and qualification activities. Proficient in preparing and executing study protocols for quality scientific experimentation aimed at troubleshooting, scaling up, or optimizing processes. Capable of interpreting experimental results and recommending process improvements, considering regulatory requirements, business objectives, and cost factors. Experienced in leading projects, technology transfers, and teams to support manufacturing activities. Knowledgeable about basic chemical and biological safety procedures. Familiar with regulatory agency requirements and preparing submissions for the biopharma industry. Experienced in participating in regulatory compliance audits. Excellent communication skills, both written and verbal, to effectively work in a cross-functional team environment. Possesses personal attributes such as integrity, trustworthiness, a strong work ethic, sound judgment, intellectual honesty, pragmatism, courage, and conviction.
US$120000 - US$130000 per year
California
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Director of Coatings Formulations
SUMMARY Our R&D team just partnered with a Global Fortune 500 Company laser focused on developing sustainable and cutting-edge science & technology for the food & beverage industry. This organization is seeking to enhance their leadership team with the addition of a scientific product development expert to spearhead their Formulation Coatings Dept and advance the next generation of technology for their global high-profile programs. RESPONSIBILITIES Lead product development efforts to design and refine coating formulations for use in beverage applications while collaborating with product development chemists. SME overseeing external and internal teams with technical support, troubleshooting for various coating solutions when any problems emerge. Visit customer's sites to learn about their application and business to optimize processes. Interpret raw data, organize results, generate/review reports, and communicate findings to project teams and management. Closely collaborate with cross-functional Depts (Regulatory, Quality, & Manufacturing, etc.) QUALIFICATIONS Ph.D. (preferred) or Masters in Chemistry (or a related scientific field) with ideally 7+ years of experience with coatings formulation (polymers ideal) Must have a strong background in new product development & innovation in coatings. Experienced in formulation design, scale-up, tech transfers, & improving manufacturing processes in adherence with regulatory standards. Hands-on experience with spray application processes (& airless spray) techniques are a PLUS! Strong leadership experience with leading teams & project management is highly desired.
US$140000 - US$180000 per year
Ohio
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Prรผfleiter Bioanalytik (m/w/d)
**Prรผfleiter Bioanalytik (m/w/d)** Sind Sie auf der Suche nach einer herausfordernden und bedeutenden Rolle im Bereich Pharma? Unser Kunde, ein renommiertes Unternehmen mit Standort in Berlin, bietet eine faszinierende Mรถglichkeit fรผr einen engagierten Prรผfleiter Bioanalytik. Dies ist Ihre Chance, Teil eines professionellen Teams zu werden und die Durchfรผhrung von bioanalytischen Studien voranzutreiben. Als Prรผfleiter Bioanalytik รผbernehmen Sie wichtige Aufgaben. Diese umfassen die: *Planung und รberwachung bioanalytischer Studien, *die Anwendung modernster LC-MS/MS Technologien und die Entwicklung von Liganden-Bindungs-Assays * Probenvorbereitung von pharmakologisch wirksamen Stoffen aus biologischer Matrix wie Blut, Plasma und Urin gemรคร GLP und GCP gerechte Dokumentation der Probenvorbereitung * Analyse, Planung und Durchfรผhrung bioanalytischer Studien, * Erstellung von Prรผfplรคnen und Reports sowie abschlieรende Archivierung Wir suchen jemanden mit folgenden Fรคhigkeiten: * Erfolgreicher Hochschulabschluss (Promotion, Diplom, Master o. รค.) der Fachrichtung Chemie * Umfangreiche Erfahrung im Laborumfeld * Erfahrung mit der Entwicklung und Validierung von Methoden zur Analyse kleiner und groรer Molekรผle aus biologischer Matrix, inklusive Probenvorbereitung * Begeisterungsfรคhigkeit und Interesse an der Probenvorbereitung und Troubleshooting * Hohe Motivations- und Teamfรคhigkeit sowie Belastbarkeit und Empathie fรผr die Analytik * Umgang mit Microsoft Office, * GxP-Erfahrung von Vorteil * Flieรendes Deutsch und Englisch Wenn diese Position Ihren nรคchsten Karriereschritt darstellen kรถnnte und wenn Sie bereit sind fรผr spannende Herausforderungen sowie das Arbeiten an innovativen Lรถsungen im pharmazeutischen Sektor - dann freuen wir uns darauf, mehr รผber Sie zu erfahren! Senden Sie bitte ihre aussagekrรคftigen Bewerbungsunterlagen unter Angabe Ihrer Verfรผgbarkeit an aida.sharififar@epmscientific.com. Wir freuen uns darauf, Sie kennenzulernen und Sie auf Ihrem Karriereweg zu unterstรผtzen.
Negotiable
Germany
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Formulation Scientist I (Solid Orals)
SUMMARY This leading global pharmaceutical company is looking for a strong Formulation Scientist to join their R&D team in support of one of the fastest growing portfolios of pharmaceutical drug products across a wide range of therapeutic areas. The ideal candidate will have strong hands-on experience with solid oral dosage forms, ANDA filing, & scale-up from lab scale to commercial manufacturing batches in a cGMP environment. RESPONSIBILITIES Lead formulation development activities as the SME for novel oral solid products Develop robust lab-scale, pilot-scale and commercial-scale manufacturing process based on Quality by Design (QbD) principles using design of experiments (DOE). Conduct GMP stability studies & analysis using the relevant industry-standard modeling tools to ensure purity and shelf life of products throughout scale-up processes. Manage tech transfers to CRO/CDMO/CMO's in collaboration with project management teams in accordance with project timelines & deliverables. Participate in cross functional meetings and provide input on strategy implementation for various projects. Author & review relevant technical documents/SOP's & FDA submissions Mentor junior staff on formulation techniques QUALIFICATIONS Ph.D. in Pharmaceutical Sciences (Or equivalent/relevant degree) with 1-2 years of drug product/formulation experience in the pharma industry OR M.S. + 4-6 years Strong experience with tablets, capsules, solid orals and scaling up to manufacturing-scale is a MUST. experience with ANDA filing is highly preferred Strong communication skills (written & verbal) Prior experience with tech-transfers or management of CRO's/CMO's is a PLUS Experience with additional dosage forms (nasal, injectables, topical, solutions, etc.) is a major plus! ADDITIONAL Fully on-site position Relocation & Sponsorship available 10% Annual Bonus + Strong Benefits Package
US$80000 - US$110000 per year
New York
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Lead Scientist
Our client is a global leading CDMO that is currently looking for a Lead Scientist to be part of their viral clearance team. As the Lead Scientist, you will be the subject matter expert, designing and leading projects. Key Responsibilities: Oversee all aspects of study planning, execution, analysis, documentation and reporting Design studies and conduct laboratory work, ensuring they are aligned with the guidelines, protocols and GMP standards. Leading and managing project teams, working with local and global teams Build, establish and maintain relationships with internal and external stakeholders Provide clear and effective communciation through reports and meetings. Requirements: Degree/ PhD in Biological Science or relevant field of study At least 5 years of lab experience, or at least 2 years and a PhD. Viral clearance experience Biologics License Applications (BLA) study experience Good understanding of cGMP regulations and quality management Excellent communication skills If you are interested in the opportunity, please apply with your CV attached.
Negotiable
Singapore
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Hardware Development Team Lead
EPM Scientific are currently mandated on a search for a Hardware Development Manager. This is an incredible opportunity to join an organisation who is at the forefront of medical device innovation. You will have the opportunity to lead a talented team of engineers and developers, guiding the creation of innovative hardware solutions that set new standards in the industry. Your expertise and leadership will be crucial in driving projects from concept to completion, ensuring that our products continue to make a difference in the lives of patients and professionals alike. Key Responsibilities: Spearhead the development of cutting-edge hardware for medical applications. Lead, mentor, and inspire a multidisciplinary team of engineers and developers. Collaborate with cross-functional teams to integrate hardware and software solutions. Oversee the entire product life cycle, from initial design to final implementation and testing. Stay ahead of industry trends and incorporate the latest technological advancements into our products. Ensure compliance with regulatory standards and quality assurance protocols. Foster a culture of innovation, continuous improvement, and excellence within the team. Your Qualifications: A degree in Electrical Engineering, Mechanical Engineering, or a related field. Proven experience in hardware development, within the medical device sector. Strong leadership skills with a track record of successfully managing and motivating teams. Expertise in project management and the ability to oversee multiple projects simultaneously. A passion for innovation and a drive to push the boundaries of what is possible in medical technology. If you want to make a real difference within the medical device industry, whilst working in a collaborative and supportive environment that values creativity and innovation, do not hesitate to apply below!
Negotiable
Munich
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Analytical Associate Scientist I/II
Analytical Associate Scientist I/II (Small Molecules and Raw Materials) Location: Florida, USA We are seeking a highly skilled Analytical Associate Scientist to join our team, specializing in Small Molecules and Raw Materials within the pharmaceutical industry. The ideal candidate will possess a strong understanding of pharmaceutical equipment and computerized systems used for operation and troubleshooting. This role requires specific expertise in analytical and/or process equipment typically found in laboratory settings, such as HPLC, IR/FTIR, UV-Vis AA, powder blenders, and other related instruments. Responsibilities: Conduct analytical testing and characterization of small molecules and raw materials using a variety of analytical techniques including but not limited to HPLC, IR/FTIR, UV-Vis AA, and powder blending. Perform method development, validation, and troubleshooting for analytical instrumentation. Collaborate with cross-functional teams to support research, development, and manufacturing activities. Document and communicate analytical results effectively, ensuring data integrity and compliance with regulatory standards. Maintain and troubleshoot laboratory equipment and instrumentation, ensuring proper functionality and performance. Requirements: Bachelor's degree in Chemistry, Pharmaceutical Sciences, Analytical Chemistry, or a related field with a minimum of 3 years of industry experience; or Master's degree with 0-2 years of industry experience; or Ph.D. with co-op experience. Strong knowledge of pharmaceutical equipment and computerized systems used in laboratory environments. Proficiency in a range of analytical techniques and instruments, including HPLC, IR/FTIR, UV-Vis AA, and powder blending equipment. Familiarity with method validation and analytical method development. Experience in troubleshooting and maintenance of laboratory equipment. Excellent communication skills, both verbal and written, with the ability to collaborate effectively in a team-oriented environment. Strong organizational skills and attention to detail. Ability to work independently and manage multiple tasks simultaneously.
US$60000 - US$70000 per year
Florida
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EMC Test Engineer
What You Will Do In our clients expanding EMC and Wireless lab, you will play a crucial role as a EMC test engineer. You will conduct electromagnetic and radio frequency tests to determine if the latest advanced products comply with EMC / Radio Equipment Directives and other international regulations. You will frequently interact with our customers, mainly via telephone, but also during their regular visits to our lab. This customer engagement makes your work more enjoyable, as you enjoy sharing experiences. Though based in our state-of-the-art lab in Arnhem, the Netherlands, you will also have access to and interact with our labs in Spain, Germany, Sterling, USA, Taiwan, South Korea, and China. This means you will collaborate with a global team of professionals! Responsibilities Performing EMC and RF tests on various products in our state-of-the-art EMC & Wireless lab Evaluating test results and preparing detailed test reports Regularly communicating with customers Assisting customers with test-related issues using your knowledge of EMC & RF directives and standards Actively contributing to the continuous improvement of the EMC & Wireless laboratory's processes, procedures, and equipment What You Bring An educational background in electrical engineering or a related field Experience in the field of EMC and RF Flexibility and the ability to multitask across various projects Strong communication skills, enabling effective interaction at different levels Willingness to work in two shifts (morning and afternoon, alternating weekly) Fluent English language skills What We Offer Competitive salary and comprehensive benefits package Variable performance bonus scheme 25 vacation days and 13 ADV (Additional Days Off) for ample relaxation Discounts on various insurance plans Numerous opportunities for career growth, supported by extensive training programs A challenging role within a cohesive team of proficient experts in a dynamic and international environment If you are interested and would like to learn more about this opportunity, apply
Negotiable
Gelderland
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Associate Scientist I/II
Associate Scientist I/II Location: Greater Miami Area Salary: 60,000 - 80,000 + Competitive Benefits Package A rapidly growing biotech company that specializes in developing inhaled drug-device products for a variety of diseases is looking to expand their laboratory operations at their Fort Lauderdale location. This biotech company is committed to expanding access to treatment by developing and commercializing lower-cost generic alternatives for diseases that have few treatment options. With a strong R&D pipeline, this biotech company is looking to onboard a world class scientific team. This company is building this department from scratch and is willing to move quickly for the right candidate. The company places a great deal of value on internal growth, thus the possibilities for career progression are limitless. The ideal candidate will be an individual looking to join a growing company with a desire to learn and grow within their role. The Associate Scientist I/II will be responsible for: Carry out laboratory tasks with minimal supervision, including analyzing raw materials, in-process substances, and finished pharmaceutical products to assess their quality, safety, purity, potency, and identity using appropriate methods, or manufacturing drug products. Adhere to cGMP, EH&S, and other relevant guidelines from Corporate, FDA, and other regulatory authorities. Independently set up and operate laboratory equipment, prepare reagents, solvents, and solutions for analytical and formulation tasks. Maintain accurate records in lab notebooks of all performed tests. Process analytical data using lab equipment such as HPLC/UPLC, enter data into spreadsheets, and perform routine calculations. Assist in the manufacture of inhalation drug products. Prepare samples for blend uniformity. Conduct equipment qualification and calibrations as instructed. Implement approved method transfer protocols. Engage in project activities, support project timelines, and actively contribute to achieving team objectives. Communicate effectively with team members. Build and sustain effective relationships with team members. Perform laboratory work according to SOPs & STPs, and follow Corporate safety rules and procedures. Adhere to all Corporate guidelines and policies. The ideal candidate will have the following: S. in Chemistry, or related fields and at least 3 years of experience in pharmaceuticals research or MSc. in Chemistry or related with 0-2 years of experience in pharmaceutical research. Proven expertise working with compendial test methods or pharmaceutical manufacturing equipment. Experience with analytical and process equipment such as HPLC, IR/FTIR, UV-Vis AA, powder blender, etc. Knowledge and understanding of FDA cGMP requirements in the pharmaceutical industry. Ability to work in a team environment as well as an individual contributor. Effective English written and oral communication skills and the ability to write technical documents such as memos, laboratory investigations, protocols, and reports.
Negotiable
Miami
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