- Provides advanced level support for execution and development of the manufacturing control strategy and Process Analytics program
- Acquires, analyses, and reports data trends using graphical and statistical methods and utilizes expertise to make recommendations to next level management based on data analysis
- Develops systems and processes for the acquisition and analysis of data trends from process, equipment, and raw materials.
- Applies statistical process control techniques to independently develop and implement (following appropriate change control) process specifications, parameters, operating ranges, and action limits.
- Supports the execution of commercial manufacturing campaigns
- Provides guidance to others on advanced and/or moderately complex theory and concepts behind the process including an understanding of the impact of any process changes or improvements, as well as the impact of any process deviations or drift
- Proactively identifies technical issues on bioprocessing equipment and recommends activities to resolve the issue. Implements procedures and activities to prevent the same issue from occurring.
- Authors standard operating procedures, reports, and protocols and solicit next level manager approval for final documents
- Advanced knowledge of statistical process control methods and data interpretation
- Knowledge of multivariate modeling techniques
- Familiarity with data engineering concept for collection, storage, and validation of data
- Demonstrated technical foundation of cell- and tissue- based products and a strong familiarity with GMP manufacturing
- Able to independently troubleshoot advanced or moderately complex bioprocess activities and perform typical and atypical bioprocess optimization studies
- Possesses advanced knowledge of the cell biological aspects of the process, as well as the engineering and mass-transfer aspects of the process
- Possesses understanding and demonstrated knowledge of equipment and procedures and identifies potential problem before they occur
- Able to communicate effectively in English, both verbally and in writing
- Possess a positive roll-up-the-sleeves attitude and optimistic outlook
- Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
- Excellent organizational and time management skills with ability to set own priorities in a timely manner
- High degree of flexibility and adaptability
- Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
- Must be able to work as needed to meet tight deadlines and at peak periods
- Self-motivated and organized critical thinker with solid interpersonal and business communication skills
- Demonstrated ability to work in a cross functional team
- Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
- Always observe safety precautions and regulations in all areas where duties are performed
- Responsible for reporting all safety hazards and potential unsafe working conditions
- Ensures Humacyte or other required trainings/certifications are up to date
- Represents the organization in a positive and professional manner
- Reports to work on time and as scheduled
- BS in Engineering or other relevant discipline required.
- MS in related discipline preferred.
- Background in chemical engineering, biochemical engineering, biotechnology, bioprocess, cell therapy, tissue engineering, regenerative medicine, or process development required.
- Minimum of 2 years of commercial manufacturing or Phase 3 CDMO or 6 years Phase 1-3 clinical manufacturing experience required.
- Demonstrated experience with the Process Validation Lifecycle and Statistical Process Control methods
- Experience with application of analytical systems and computational methods to biological systems in a GMP environment
- Demonstrated experience leading basic troubleshooting and participating in complex troubleshooting/
- Possess a demonstrated technical foundation of cell- and tissue- based products.
- Experience with bioprocessing deviations, change control, process optimization, and technical troubleshooting.
- Works well in a team environment.
- Strong experience working cross functionally within a BioPharma Bioprocessing organization.
- Stock Options
- 401k Plan with 4% Match and no Vesting Schedule
- Medical, Vision and Dental Plans
- Company Paid Long Term/Short Term Disability
- Company Paid Life Insurance
- 23 Days Paid Time Off (PTO)
- 10 Company Designated Holidays + 2 Floating Holidays
- Paid Parental Leave Policies
-
Senior MSAT Process Engineer
3 days ago
HUMACYTE GLOBAL INC Durham, United StatesJob Description · Job DescriptionCOMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and tran ...
-
Senior MSAT/Process Engineer
2 weeks ago
HUMACYTE GLOBAL INC Durham, United StatesJob Description · Job Description · Humacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on improving lives of patients and transforming the practic ...
-
MSAT Engineer II-Analytics
3 weeks ago
Humacyte Durham, United StatesHumacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on improving lives of patients and transforming the practice of medicine. Located in Durham, NC, ...
-
Senior MSAT/Process Engineer
1 week ago
HUMACYTE GLOBAL INC Durham, United StatesJob Description · Job DescriptionHumacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on improving lives of patients and transforming the practice of ...
-
Process Engineer II
1 week ago
Asklepios Biopharmaceutical Durham, United StatesAsklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicin ...
-
Process Engineer II
2 weeks ago
Asklepios Biopharmaceutical Durham, United StatesAsklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicin ...
-
Process Engineer II
1 week ago
Asklepios Biopharmaceutical Durham, United StatesAsklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicin ...
-
Process Engineer II
3 weeks ago
Asklepios Biopharmaceutical Durham, United StatesAsklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicin ...
-
Senior Process Engineer
3 weeks ago
Asklepios Biopharmaceutical Durham, United StatesAsklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicin ...
-
Senior Process Engineer
2 weeks ago
Asklepios Biopharmaceutical Durham, United StatesAsklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicin ...
-
Senior Process Engineer
2 weeks ago
Asklepios Biopharmaceutical Durham, United StatesAsklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicin ...
-
Associate Director, MSAT
3 weeks ago
Asklepios Biopharmaceutical Durham, United StatesAsklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicin ...
-
GlaxoSmithKline Durham, United StatesSite Name: USA - Pennsylvania - Upper Providence, Durham Blackwell Street, UK - Hertfordshire - Stevenage, Waltham · Posted Date: May 3 2024 · The Strategic External Development (SED) team is an empowered, innovative, and agile CMC development organization within MDS that will un ...
-
Eli Lilly and Company Durham, United States Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve th ...
-
Sarepta Therapeutics Burlington, United StatesWith the exciting advancement of multiple gene therapy programs from early clinical to pivotal and commercial stages, we are actively recruiting for Principal Engineer/Senior Manager to support Sarepta's diverse gene therapy portfolio and to deliver new treatments for patients. T ...
-
Pharmaceutical - VALIDATION ENGINEER
2 weeks ago
MMR Consulting Inc Raleigh, United StatesJob Description · Job Description Salary: · Pharmaceutical - VALIDATION ENGINEER · Previous · Pharmaceutical/Biotech · experience is mandatory for this role · MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industrie ...
-
Pharmaceutical - VALIDATION ENGINEER
1 week ago
MMR Consulting Raleigh, United StatesJob Description · Job DescriptionSalary: · Pharmaceutical - VALIDATION ENGINEER · Previous Pharmaceutical/Biotech experience is mandatory for this role · MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industries in the ...
-
Staff Associate Scientist
1 week ago
GRAIL, LLC Raleigh, United States Full timeGRAIL is seeking a Staff Associate Scientist (SAS) for the MSAT Reagent QC group in RTP, NC. This position is to support Reagent QC testing and laboratory management in a GMP laboratory setting. The Reagent QC laboratory utilizes several QC methods including NextGen Sequencing, p ...
-
Equipment Technician 3
3 weeks ago
GRAIL, LLC Raleigh, United States Full timeGRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power o ...
MSAT Engineer II - Durham, United States - HUMACYTE GLOBAL INC
Description
Job Description
Job DescriptionHumacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on improving lives of patients and transforming the practice of medicine. Located in Durham, NC, the company develops and manufactures acellular tissues for the treatment of diseases and conditions across a wide range of therapeutic areas. The company's innovative technology supports tissue repair, reconstruction, and replacement while overcoming limitations in existing standards of care. Initially developing a portfolio of human acellular vessels (HAVs), to target multiple vascular markets including trauma, arteriovenous access for hemodialysis, peripheral arterial disease, and coronary artery bypass grafting. Humacyte is focused on the development of future markets such as pediatric heart surgery, delivery of cellular therapies, and multiple other novel cell and tissue systems.We are looking for additional colleagues to continue to build our expanding team. Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrate the ability to work in a team environment and lead other professionals and peers.
Position Background:
The MSAT Engineer - Analytics will support the development and execution of process analytics, process support, and control strategy activities with limited supervision and guidance. This role will be ~50% process analytics and 50% process engineering support. This role will collaborate effectively with personnel in Manufacturing, Engineering, Process Development, Quality Assurance, and Quality Control utilizing strong communication, and technical expertise to maintain and improve manufacturing operations.
Remote Work Designation: Not Remote
Major Accountabilities:
Special Competencies:
General Competencies:
Qualifications:
Perks:
**Please note, Humacyte does not provide sponsorship at this time and does not accept unsolicited resumes from recruiters.**
#LI-Onsite
