Arraylist Methods Jobs in Usa

Position Summary:

The Associate Director, Quality Control will be responsible for providing strategic, scientific, and operational leadership for the development, qualification, validation, and lifecycle management of analytical methods supporting Upstream Bio’s lead program verekitug. This role will manage and execute GMP quality control (QC) activities directly related to batch release for clinical trial material supply. The leader in this role must assure that quality controls for investigational new drugs (investigational medicinal products) meet all quality requirements, regulatory standards, and meet continuous clinical supply and delivery expectations. The Associate Director will report to Senior Director of Analytical and serve as a key partner to Quality, CMC, Regulatory, and cross-functional teams. This individual will provide technical guidance and business acumen to ensure execution of analytical activities for late-stage programs through BLA/MAA submission, approval, and commercial launch.

Key Responsibilities:

• Author, review and approve analytical method procedures/SOPs
• Author, review and approve analytical method transfer/qualification/validation protocols and reports
• Manage external CDMOs and CROs to execute Development and GMP release and stability testing of Drug Substance and Drug Product in a compliant-manner
• Establish and manage reference standard and critical reagent programs
• Participate in the laboratory quality system activities such as internal audits, writing standard operating procedures, and documentation review.
• Perform data verification and audits in order to ensure accuracy of data and analytical processes.
• Ensure compliance with company policies and SOPs as well as global health authority guidelines.
• Create, analyze, verify, and approve QC data such as method validation, release and stability, results, reports, and Certificates of Analysis (COAs).
• Generate, review, and revise specifications, SOPs, and other QC laboratory and testing documentation.
• Lead Out-of-Specification (OOS), Out-of-Trend (OOT), and Deviation investigations related to the QC laboratory and ensure effective corrective and preventive actions (CAPAs) are implemented.

Qualifications:

• Experience in stability study performance/evaluation and/or knowledge/familiarity with USP/compendial testing is helpful.
• Excellent verbal and written communication/interpersonal skills, problem-solving skills, organizational skills, and the ability to work in a diverse team environment are essential.
• Proficiency with Microsoft software (Word / EXCEL / PowerPoint), Stability software and statistical analysis/trending to support shelf life and labeling is expected.

Knowledge and skills (general and technical) preferred:

• Broad background, strong comprehension, and demonstrated skills in analytical methods development/validation/transfer/similar, reference standards characterization/structural elucidation, and unknown identification.

Education level and/or relevant experience required:

• Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 10+ years of demonstrated success in leading cross-functional teams and managing projects along with 7+ years relevant analytical experience in a cGMP-compliant pharmaceutical laboratory environment. Any ASQ or other certifications is a plus.

About Upstream Bio:

Upstream Bio is a public company based in Waltham, MA. We are developing verekitug, the only known antagonist currently in development that targets the receptor for Thymic Stromal Lymphopoietin (TSLP). We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) and plan to initiate development in chronic obstructive pulmonary disease (COPD). Our experienced team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. Learn more about us at .

Compensation

Target Salary Range: $176,400 - $215,600

*Base Compensation for this role will depend on a number of factors including a candidate’s qualifications, skills, competencies, and experience. Base pay is only one component of the company’s total rewards package. All regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.

The role:

The Quality Control Scientist is responsible for execution and oversight of analytical, microbiological, and environmental testing to ensure the safety and quality of cell therapy products and manufacturing operations. The role includes performing GMP testing to support development, donor screening, in-process control, product release, stability, raw material release, and environmental monitoring in accordance with Standard Operating Procedures (SOPs). The QC Scientist serves as a technical resource for analytical methods such as flow cytometry and other cell-based assays, supports assay and equipment qualification, and ensures data integrity and regulatory compliance. Additional responsibilities include authoring or revising procedures, leading continuous improvement initiatives, supporting investigations, contributing to assay development efforts, and train staff as needed.

In the role you will:

• Perform analytical, microbiological, and environmental testing in support of development, donor-screening, in-process control, product release, stability, and raw-material release in accordance with SOPs and GMP requirements.
• Serve as a technical lead for flow-cytometry–based analytical assays, including instrument setup, compensation, gating strategy, data analysis, and troubleshooting.
• Perform and review cell count assays and evaluate data.
• Support method qualification, validation, and transfer for flow cytometry, cell counting, and other analytical assays; ensure accurate, reproducible data generation.
• Conduct environmental and personnel monitoring of controlled areas, including viable air, non-viable particulates, surface, and gowning monitoring.
• Oversee environmental data entry, review, and trend analysis; evaluate results against alert and action levels and support investigations for excursions or adverse trends.
• Execute and review microbiological assays such as sterility, endotoxin (LAL), bioburden, gram staining, growth-promotion, and conductivity/TOC testing.
• Participate in aseptic process simulation (media-fill) runs; provide on-floor QC support during execution and perform subsequent media incubation, inspection, and documentation.
• Sample, test, and document raw-material results and manage disposition.
• Establish and manage relationships with qualified contract laboratories; oversee external testing activities, ensure timely data delivery, review results, and verify accuracy for inclusion in release documentation.
• Compile, verify, and review analytical and microbiological data to support generation of Certificates of Analysis (CoA) for raw materials, intermediates, and drug-product release.
• Oversight of stability testing for intermediates and product to support shelf-life claims and IND submission.
• Author and revise SOPs, test methods, and data records; contribute to laboratory continuous-improvement initiatives.
• Author and revise technical reports and support IND submissions.
• Support and provide technical input to deviation, OOS, and CAPA investigations, ensuring scientific rationale and data integrity.
• Participate in equipment calibration, qualification, and maintenance programs, and assist in implementation of new or revised analytical methods.
• Train staff in flow cytometry, microbiological methods, and GMP documentation practices.
• Maintain compliance with GMP, data-integrity, and safety requirements, ensuring laboratory readiness for internal and regulatory inspections.
• Provide input to QC metrics and data-trending reports for management review.
• Maintain a flexible schedule to accommodate manufacturing and testing demands, including periodic weekend, holiday, or extended-hour work and off-shift coverage as needed.

Qualifications: About you

• Minimum 4-6 years relevant QC experience in a GMP and cleanroom environment, supporting biologics or cell therapy products.
• Demonstrated proficiency in analytical and microbiological testing, including flow cytometry, cell counting, endotoxin, sterility, and environmental monitoring.
• Proven experience supporting method qualification, validation, and transfer activities.
• Strong understanding of data review, good documentation practices, and data integrity.
• Experience conducting and authoring investigations, CAPA development, and laboratory deviation documentation.
• Experience collaborating cross-functionally with Manufacturing, QA, and Analytical Development teams to support GMP operations.
• Requires Bachelor’s degree in a scientific discipline or equivalent combination of education and experience.
• Expertise in flow cytometry, including instrument setup, compensation, gating, and data analysis.
• Experience leading method qualification, transfer, and troubleshooting for analytical and microbiological assays.
• Advanced understanding of aseptic technique and contamination control in GMP cleanroom operations.
• Experience performing or reviewing microbiological assays, including endotoxin (LAL), sterility, bioburden, gram staining and growth-promotion testing.
• Familiarity with environmental and personnel monitoring, including data trending and evaluation against alert/action levels.
• Experience performing or reviewing in-process and release testing for cell-based products.
• Strong knowledge of raw material testing programs, including identity, endotoxin, and bioburden verification.
• Experience coordinating and reviewing external testing with qualified contract laboratories.
• Proficiency in data review, trending, and reporting using paper or electronic based systems.
• Strong understanding and ability for authoring f GMP documentation, investigations, and change controls.
• Ability to train and qualify analysts in technical procedures and GMP compliance.
• Proactive, self-motivated team player who is comfortable working in a dynamic, fast-paced manufacturing setting, working independently with minimal supervision and adapting to changing schedules.

The targeted salary range for this position is $95,000 - $129,600 per year. MiNK is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offered is commensurate with MiNK's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, critical needs of the role, and internal equity.

Company Overview

Founded in 1976 and headquartered in Redmond, Washington, MicroSurgical Technology's passion is creating exceptional surgical devices and instruments used to restore or improve sight for patients all over the world. MST is part of UK based Halma PLC, a global company whose healthcare division helps provide technologies and solutions that enhance the quality of patients’ lives.

Our products are surgeon-designed and meticulously crafted to instill confidence and assurance in Cataract and Glaucoma procedures and include a wide range of surgical instruments such as forceps, scissors, hooks, spatulas, and knives, all designed for the delicate and intricate procedures required in microsurgery.

Together, we create a place where we are successful, motivated by our mission and inspire each other. This is where you can do your best work!

Senior Manufacturing Engineer

Responsibilities:

• Design new and revise existing tools and fixtures for assembly, test, and inspection
• Create test protocols for qualifying new products and assemblies
• Develop and document IQ, OQ, PQ and maintenance protocols for new equipment and fixtures
• Develop and implement automation/semi-automation equipment and fixtures
• Participate in Material Review Board, evaluate and disposition discrepant material, conduct failure root cause analysis, develop rework and repair methods, identify and document corrective and preventative action
• Create engineering design and process change orders with required documentation, technical justification/change effects analysis, and impact to operations
• Create, document, and conduct training and certifications for fixture/equipment operation, and critical methods
• Revise existing product designs for improvement or new line extensions
• Develop test equipment and methods for mechanical, electrical, hydraulic, and pneumatic devices and systems
• Develop and maintain production assembly, test, and inspection procedures through product life cycle
• Develop verification and validation protocols for equipment and processes, including validation of cleaning, packaging, and sterilization
• Develop automated data collection and reporting methods
• Lead production process quality improvement
• Determine training and certification requirements for assemblers and technicians for production processes and equipment
• Provide product failure analysis support for customer complaints and returns
• Workflow design, yield improvement, waste reduction, time and motion efficiency studies
• Create and maintain Product and Process FMECA through product life

Requirements:

• Bachelor’s degree in Engineering (Manufacturing, Mechanical, or equivalent) with 5-7 years of experience in medical device manufacturing or related manufacturing environment
• Direct experience in medical device or highly regulated environment
• Certified SolidWorks Associate or 3+ years of equivalent experience
• Microsoft Office applications, Excel power user
• Proficiency with inspection tools and methods
• Solid understanding of design change requirements and processes in FDA regulated manufacturing environment
• Ability to perform Gage R & R Analysis for equipment qualifications
• Ability to use Design of Experiments methods to support process improvement

Desirable Skills and Experience:

• Experience with metal machining and fabrication and finishing methods and equipment
• Swiss watch or jewelry manufacturing industry with insights into small tools, equipment, techniques
• Experience with color anodizing, electropolishing, chemical etching, laser etching
• Clean room, aqueous cleaning, and sterilization qualification and monitoring
• Lean manufacturing process implementation or support
• Mechanical specification using GD&T
• Quality analysis using MiniTab

Salary range for this position is $120k-$145k per year which is the general base range for a successful candidate in the State of Washington. The successful candidate’s actual pay will be based on various factors such as skills, qualifications and experience.

This role is also eligible for a competitive benefits package that includes medical, dental, vision, life, and disability insurance; 401K retirement plan; flexible spending and health savings account; paid holidays; paid time off; parental leave; employee assistance program and other company benefits.

MicroSurgical Technology Inc. is an equal opportunity employer and does not discriminate based on gender, sex, age, race and color, religion, marital status, national origin, disability, sexual orientation, gender identity or expressions, veteran status, or any other category that is protected by applicable law.

Please note that only qualified candidates will be contacted for further consideration.

No Recruiters or Agencies Please

Pay Rate: up to $30/hr on w2 (No C2C or 3rd parties)

Location: Onsite in Fort Worth, TX

• Ensure that lab cleanliness and safety standards are maintained.
• Develop and qualify new testing methods.
• Train other analysts to perform laboratory procedures and assays.
• Perform visual inspections of finished products.
• Participate in internal assessments and audits as required.
• Identify and troubleshoot equipment problems.
• Evaluate new technologies and methods to make recommendations regarding their use.
• Serve as a technical liaison between quality control and other departments, vendors, or contractors.
• Coordinate testing with contract laboratories and vendors.
• Write technical reports or documentation such as deviation reports, testing protocols, and trend analyses.
• Write or revise standard quality control operating procedures.
• Supply quality control data necessary for regulatory submissions.
• Receive and inspect raw materials.
• Review data from contract laboratories to ensure accuracy and regulatory compliance.
• Prepare or review required method transfer documentation including technical transfer protocols or reports.
• Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines.
• Participate in out-of-specification and failure investigations and recommend corrective actions.
• Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, or protocols.
• Investigate or report questionable test results.
• Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.
• Identify quality problems and recommend solutions.
• Evaluate analytical methods and procedures to determine how they might be improved.
• Complete documentation needed to support testing procedures including data capture forms, equipment logbooks, or inventory forms.
• Calibrate, validate, or maintain laboratory equipment.
• Compile laboratory test data and perform appropriate analyses.
• Conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples.

SUMMARY:

The manufacturing engineer develops and implements optimal, cost-effective manufacturing processes and methods in accordance with product specifications and quality standards; recommends and implements improvements to production processes, methods and controls; coordinates manufacturing launch for new or revised products.

DUTIES AND RESPONSIBILITIES:

• Evaluates manufacturing processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors when needed; soliciting observations from operators.
• Develops manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors when needed.
• Improves manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.
• Assures product and process quality by designing testing methods; testing finished- product and process capabilities; establishing standards; confirming manufacturing processes.
• Provides manufacturing decision-making information by calculating production, labor, and material costs; reviewing production schedules; estimating future requirements.
• Prepares product and process reports by collecting, analyzing, and summarizing information and trends.
• Provides manufacturing engineering support for manufacturing processes and equipment.
• Maintains product and company reputation by complying with government regulations.
• Keeps equipment operational by coordinating maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service when needed.
• Completes design and development projects by training and guiding technicians.
• Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies (Where applicable).

SUPERVISORY RESPONSIBILITIES:

• This job has no direct supervisory responsibilities
• Potential project management responsibilities.

QUALIFICATIONS / SKILLS:

• Bachelor's Degree from four-year college or university, or 6 to 8 years of related experience and/or training, or equivalent combination of education and experience.
• Computer skills required: Microsoft Office; Statistical Analysis Software (i.e. MiniTab / JMP)
• Ability to design and execute a DOE
• Technical Writing; including validations and technical reports
• Ability to analyze data based on statistical methods
• Problem-solving skills
• Communication internally & externally
• Leadership
• Equipment Specifications
• Manufacturing Methods and Procedures
• Product Development
• Presenting Technical Information
• Analytical skills
• Relevant technical knowledge
• Teamwork

COMPANY COMPETENCIES:

• Diversity - Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Builds a diverse workforce.
• Ethics - Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
• Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
• Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
• Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.

JOB COMPETENCIES:

• Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.
• Change Management - Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results
• Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.
• Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
• Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.

PHYSICAL DEMANDS AND WORK ENVIORNMENT:

• Frequently required to stand, walk and sit
• Occasionally required to utilize hand and finger dexterity
• Occasionally required to climb, balance, bend, stoop, kneel or crawl
• Continually required to talk or hear
• Occasionally work near moving mechanical parts
• Occasionally work around fumes, airborne particles, or toxic chemicals
• While performing the duties of this job, the noise level in the work environment is usually moderate.
• The employee must occasionally lift and /or move more than 25 pounds
• Specific vision abilities required by this job include: Close vision; Distance vision; Color vision; Peripheral vision; Depth perception and ability to adjust focus

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess’ patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.

The Role

We are seeking a motivated and detail-oriented Research Associate with strong hands-on experience in chromatographic analysis to support QC release and stability testing. The successful candidate will perform routine cGMP QC testing using HPLC methods (RP-HPLC, SEC, IEX), Agilent HPLC systems, and additional supporting assays in a fast-paced, collaborative environment. This is a unique opportunity to be part of an emerging early-phase clinical company bringing innovative technology to the global market.

Key Responsibilities

• Perform routine QC release and stability testing using HPLC methods including RP-HPLC, SEC, and IEX.
• Prepare samples, operate Agilent HPLC systems, verify system suitability, and ensure analyses meet method and specification requirements.
• Execute complementary analytical assays such as UV-Vis, pH, surface tension, and mechanical tests.
• Maintain complete, accurate documentation in compliance with cGMP, ALCOA+, and data integrity requirements.
• Conduct routine instrument care (solvent flushes, column care, daily checks) and assist troubleshooting under supervision.
• Process and review chromatographic data in Agilent OpenLab CDS.
• Support method qualification, validation, and transfer activities by executing protocols and recording observations.
• Maintain calibration, maintenance, and service records for analytical instrumentation.
• Independently author method SOPs, analytical protocols, technical reports, and contribute to regulatory submissions.
• Collaborate cross-functionally with QC, Analytical Development, Process Development, Manufacturing, and Regulatory teams to enable program success.
• Maintain rigorous laboratory documentation and complete, audit-ready analytical records.
• Thrive in a fast-paced, cross-functional environment with excellent communication and organizational skills.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or related field with 1–3 years of experience; or a master’s degree with relevant laboratory experience.
• Hands-on experience operating HPLC systems; Agilent systems and OpenLab CDS experience strongly preferred.
• Practical experience with chromatographic techniques including RP-HPLC, SEC, and IEX.
• Experience supporting QC release or stability testing in a GMP/GLP environment.
• Strong attention to detail and ability to follow SOPs precisely.
• Excellent documentation practices and understanding of data integrity.
• Strong organizational skills with the ability to manage multiple workflows and prioritize effectively in a fast-paced environment.
• Excellent verbal and written communication skills and comfort working within interdisciplinary teams.
• Commitment to collaborative work within interdisciplinary project teams.

At Vaxess, we’re bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to

Work Shifts

9:00 A.M – 5:00 P.M

Duties & Responsibilities

Purpose of Position:

Under varying degrees of direction, with broad latitude for the exercise of independent judgment, acts as an expert consultant and advisor on complex and important management problems, with particular reference to business organization and methods. All personnel perform related work.

Examples of Typical Tasks:

Under direction, performs the following typical tasks:

1. Provides expert consultant services for the use of executives, department heads, other departmental personnel, and to inter-corporate facilities or City-wide committees on business organization and methods, and the establishment and implementation of programs for the evaluation, improvement and regularization of normal business operations.

2. Engages in research on business organization and methods to assist in the development and installation of methods and techniques of general application in wide areas of departmental determination and execution or achievement of management policies, objectives and goals.

3. Prepares or supervises the preparation of reports on departmental organization and administration of normal business operations in the light of study and analysis of surveys designed to secure optimum efficiency, economy and adequacy of public service and convenience.

4. Conducts or supervises the conduct of special studies of assigned complex and important management problems.

5. Participates in the establishment and maintenance of effective cooperation and liaison with executive personnel in City departments and agencies, other government agencies and private agencies concerning problems and activities in the area of business organization and methods or the conduct of special studies of management problems.

Minimum Qualifications

1. A Master's degree in public administration or business administration, or in an equivalent or equally acceptable program, and four (4) years of satisfactory, full-time paid experience in a major governmental agency or large corporation or foundation in management analysis or in operational direction, planning, coordination or control of which two (2) years must have been in a supervisory, administrative or consultative capacity; or

2. A Baccalaureate degree from an accredited college or university and five (5) years of experience as stated in #1 above of which three (3) years must have been in a supervisory, administrative or consultative capacity; or

3. A satisfactory equivalent, however, all candidates must possess not less than the two (2) years of supervisory, administrative or consultative experience required.

Four (4) years of appropriate general experience may be substituted for a Baccalaureate degree requirement. Appropriate full-time teaching experience in an accredited college or university may be substituted on a year-for-year basis for the required general experience and appropriate full-time teaching experience in a position of professional rank may be substituted on a year-for-year basis for the required supervisory, administrative or consultative experience.

Department Preferences

Educational Level:

• Graduate Degree

Special Equipment/Machines Operated:

• MS Office
• Peoplesoft Financials
• FMS

Knowledge, Skills, Abilities and other Requirements:

• Capital Eligibility
• Financial Analysis and Controls
• Strong Written and Verbal Communication Skills
• Excellent Customer Service to internal Stakeholders
• Detailed Oriented and Organized

The Senior Scientist will play a key role in the development, optimization, transfer, qualification, monitoring, and execution of molecular analytical methods supporting gene therapy process development and/or Manufacturing. If you are looking to be part of a highly technical environment with opportunities for growth and new challenges, this role may be the perfect fit for you!

Responsibilities:

• Lead and execute molecular method development, optimization, transfer, qualification, monitoring, and lifecycle management to support gene therapy process development/manufacturing and transfer to GMP testing.
• Design, perform, and interpret complex experiments with minimal supervision to evaluate vector genomes and related molecular attributes using nucleic acid–based technologies (qPCR, dPCR, ddPCR).
• Provide robust in-process analytics and product characterization support for analytical assays that support Process Development and/or Manufacturing, including support of investigations and technical troubleshooting.
• Present data and project updates at cross-functional meetings and contribute to scientific discussions and decision-making.
• Support analytical method qualification activities, continuous improvement initiatives, and data review processes to ensure scientific rigor and regulatory alignment.
• Work with molecular assays as a primary responsibility and, as needed, support analytical testing across additional assay platforms

Education/ Qualifications:

• Bachelor’s or Master’s degree in Molecular Biology, Biochemistry, Cell Biology, Immunology, or related discipline with 6–10 years of relevant industry experience, or a PhD with 3–5 years of industry experience preferred.
• Demonstrated experience in development, optimization, transfer, and execution of molecular analytical methods, particularly PCR-based assays (qPCR, dPCR/ddPCR) for nucleic acid quantification and characterization.
• Experience supporting gene therapy programs, including molecular assays for vector genome titer, residual DNA analysis, and other nucleic acid–based characterization methods.
• Strong expertise in assay troubleshooting, experimental design, and data analysis to support process development, method qualification, and product characterization

Job Summary

Provide analytical support and data generation for daily chemistry testing activities related to raw materials, in- process and finish products. Perform all testing in a timely and accurate manner in accordance with approved GMP documents (test methods, Specifications, SOPs).

Chemist I

Essential Functions:

• Inspects components, products and/or processes to ensure conformance with standards.
• Executes laboratory procedures for sample preparation
• Performs materials analysis of substantial variety & complexity using ARx test methods, compendia methods, specifications with minimal supervision.
• Ensure all analytical operations comply with cGMPs & ARx procedures and all laboratory experiments are properly documented in notebook and are in accord with regulatory requirements.
• Provide support to routine USP water and environmental testing.
• Works with minimal supervision/direction in expediting completion of laboratory assignments.
• Abide by the ARx Laboratory Chemical Hygiene Plan and other safety policies. Maintains a safe and clean work environment, notifying the supervisor of unsafe practices, conditions, or acts; L-II takes on increasing responsibility for surfacing and implementing improved safety practices.
• Responsible for following all applicable waste handling procedures.

Additional Responsibilities:

• Completes required paperwork / documentation accurately, neatly and in a timely manner.
• Responsible for the proper disposal of hazardous waste into the proper labeled containers and drums.
• Performs other duties and responsibilities as assigned.
• Make identifiable and substantial contributions to continuous improvement. Performs all duties consistent with established ARx guideline consistent with all regulatory requirements. Actively complies with and endorses Department and Company objectives.

Job Specifications:

• BS (or higher) degree in Chemistry, Microbiology, or closely related discipline and 0-2 years lab experience (preferably pharmaceutical GMP) or requires high school education and 5 years minimum lab experience (preferably pharmaceutical GMP).
• Knowledgeable in the application of various analytical techniques such as chromatography and spectroscopy; thermal analysis and wet chemistry techniques desired.
• Basic knowledge and understanding of scientific principles involved in the performance of analytical test methods.
• Ability to efficiently utilize time (coordinate several assignments concurrently).
• Ability to read and interpret documents such as test methods and procedure manuals.
• Knowledge of requirements for maintaining proper laboratory otebook documentation
• Must have above average computer skills and knowledge; specially in the operational use of analytical equipment have a computer interface.
• Ability to perform basic mathematical functions and apply basic concepts such as mean and standard deviation.
• Good communication skills (verbal and written).
• Excellent interpersonal skills.
• Requires common physical characteristics and abilities, such as above average agility and dexterity; physical exertion such as long periods of standing, recurring bending, crouching, stooping, stretching, reaching or similar activities should be expected.
• Work environment involves moderate risks or discomforts requiring special safety precautions, will be required to use personal protective equipment.

Physical Demands:

Sitting: 67-100%/day

Standing: 67-100%/day

Walking: 67-100%/day

Kneeling: 1-33%/day

Reaching: 1-33%/day

Overhead Reaching: 1-33%/day

Crawling: Never

Twist/Pivot at Waist: 1-33%/day

Bending: 1-33%/day

Upward Gaze: 1-33%/day

Downward Gaze: 1-33%/day

Squat: 1-33%/day

Balance: Rarely

Light Grasping: 1-33%/day

Heavy Grasping: Rarely

Fine Motor: 1-33%/day

Foot Pedal: Rarely

Hand Controls: 34-66%/day

Ray Therapeutics mission is to restore vision to people with retinal degenerations. RayTx is using a novel bioengineered optogenetic protein optimized for human vision delivered by AAV to restore visual function in a mutation agnostic approach and without the need for light enhancing eyewear. The company is developing its lead candidate RTx-015 in retinitis pigmentosa, a degenerative retinal disease with significant unmet medical need as well as a pipeline to treat both rare and large market indications.

We are currently seeking an exceptional team member to join our team as a CMC Technical Development Specialist. This role will report to the Senior Director, CMC Analytics, and will have an active role supporting the general CMC department as well as our process, product management, and MSAT teams. The position requires hands on support for AAV analytical development, transfer, and qualification through validation support for our lead candidates from Pre-IND to BLA. The role is based in the Berkeley, CA office with a hybrid work from home/in office requirement and may require travel to our external vendors at in the United States. If the lab is where your curiosity comes alive and breakthroughs spark your excitement, this position may be right for you.

The job duties and responsibilities include but is not limited to the following:

• Collaborate with analytical development and process development teams to develop, qualify and/or validate AAV gene therapy assays.
• Develop analytical methods and support method optimization/characterization.
• Independently execute analytical assays including molecular biology assays, chemical/biochemical assays, and cell-based biological potency assays, for internal CMC commitments, process monitoring, release and stability.
• Develop protocols for analytical transfer, qualification and /or validation studies and execute associated wetlab work.
• Present aasay methodology and principles to external partners and support method transfers.
• Execute routine assays with high presicion and provide data summaries and reports in a timely manner.
• Document all raw data, method plans, and summarize conclusions.
• Author and review Test Methods, Reports, and Protocols.
• Work in the lab independently and in a collaborative environment with minimal guidance.
• Support CMC outside of analytical teams to move programs forward, e.g. shelf-life determination, upstream characterization etc.

Qualifications and Experience:

• BA/BS in Biochemistry, Biology, bioengineering or a related fields and at least 10 years of Biotech/pharmaceutical industry experienced required.
• Experienced in compendial methods, CE-SDS, gel electrophoresis, HPLC, DLS, ddPCR or qPCR, ELISA, and cell based potency assays.
• Hands on experience in AAV gene therapy analytical methods and testing required.
• Experience in precision pipetting and cell culture (handling, aseptic techniques, maintenance), plate-based imaging, ELISAs, luminescence and fluorescence detection techniques.
• Curiosity and good scientific knowledge and acumen.

Compensation Range and Benefits:

• For this role, the anticipated base salary range: $145,000 to $160,000, based on the candidate's professional experience level. The final salary offered for this position may take into account a number of factors including, but not limited to skills, education, and experience.
• Ray Therapeutics also offers annual performance-based bonus, annual equity awards and a comprehensive benefits package.

At Ray Therapeutics, we celebrate diversity and are committed to creating an inclusive environment for all employees; providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.

All employment is decided on the basis of qualifications, merit, and business need.

Search Firm Representatives Please Read Carefully

Ray Therapeutics does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Please, no phone calls or emails.