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Are you an experienced Sr Research Associate with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Sr Research Associate to work in Novato, CA.

Position Summary: The selected candidate will work in the Separations and Biophysical Assays team within the Analytical Sciences group to assist in the advancement of clients' therapeutics for clinical evaluation and potential commercialisation. The candidate will be responsible for method development (separations), provide routine testing and characterization support to partner groups to help with early candidate selection, process development, and drug substance and drug product process characterization. The ideal candidate will have hands-on experience working with biologics including but not limited to proteins, peptides, protein-conjugates, enzymes, biologics with a focus on method development and in-depth characterization. The ideal candidate will be able to perform quality work under limited supervision, apply problem solving techniques to maintain accurate results, promote improvements, and assure a safe, stable, on-target operation within the laboratory. The selected candidate should possess excellent analytical, organizational and communication skills and be a self-starter willing to work efficiently and collaboratively in a dynamic environment. This role is primarily a laboratory position; contact with chemicals is part of the job. The role is fully onsite (5 days a week, 8-hour days) with occasional evening or weekend work required. The employee will be trained to use common lab equipment and minimize exposure to hazards. Desktop or laptop computer work is also a major component of the job. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, knee crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities in this job include close vision, depth perception and ability to adjust focus.

Primary Responsibilities/Accountabilities:

• Primary responsibility is to support the Separations and Biophysics group within Analytical Sciences
• Be a hands-on presence in the laboratory, supporting biophysical/ biochemical assay development and qualification using HPLC and CE (must have) for various modalities (preferably biologics). LC-MS (high-res) experience is also desirable.
• Provide routine analytical characterization & testing support to partner groups including Upstream and Downstream PD, Formulations, and Research & Early Development (RED).
• Document experimental results in the company electronic lab notebook (Benchling), author procedures, and contribute to technical documentation (test methods, development reports).
• Actively participate in the operational aspects of the laboratory by conducting safety inspections, lab organization, ordering supplies, and performing routine equipment maintenance.
• Present scientific literature and results from ongoing studies at group meetings and other discussion forums at the company.
• Other duties as assigned.

Qualifications:

• Bachelor's degree in Chemistry, Biochemistry, Analytical Chemistry, Chemical Engineering or a related field with 6+ years of experience in a Biologics or Pharmaceutical environment.
• Master's degree in Chemistry, Biochemistry, Analytical Chemistry, Chemical Engineering or a related field with 4+ years of experience in a Biologics or Pharmaceutical environment.
• Hands-on experience in the biotechnology industry or academic setting with a broad range of analytical techniques focused on analytical testing and characterization for proteins, peptides, and protein-conjugates is required.
• Experience with biochemical characterization methods is required:
• SEC, SCX, RP-HPLC experience is a must (Agilent/Waters/Thermo LC instruments)
• Capillary Electrophoresis (PA800 or BioPhase8800) based methods (SDS for size separation, glycan profiling)
• cIEF (Maurice) experience is highly desirable
• LC-MS (Orbitrap/QToF/QQQ) method development experience also desirable
• Technical understanding of all aspects of analytical testing, phase appropriate regulatory requirements, method qualifications, and method transfers.
• Ability to independently troubleshoot issues, ideate, and develop insights into technical challenges and propose solutions to solve them.
• Demonstrates attention-to-detail and "right-the-first time' approach
• Excellent written and oral communication skills, with the ability to communicate complex information. Be able to present data/ideas to functional and cross-functional teams.
• Ability to influence others effectively and develop collaborative relationships with partner teams.
• Familiar with use of statistical software, electronic document management, and laboratory information management.
• Ability to effectively analyze complex problems and present results effectively within and beyond the department
• Ability to flexibly adapt to changing business needs and meet timelines.
• Strong organizational skills with the ability to effectively multi-task and prioritize.

Preferred:

• Experience in method development, qualification, and transfer to/from other laboratories, such as development and quality control.
• Knowledge of biopharmaceutical process development is a plus.
• Experience with automation is a plus.
• Experience working in a cross-functional environment.
• Good understanding of root cause analysis methodology.

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.

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 talented, collaborative, and highly motivated individual with expertise analytical methods highly focused on HPLC and QC operations to join our core team of scientists and engineers. The Senior Scientist will execute Quality Control testing, and associated operations and contribute to analytical testing to ensure compliance with cGMP requirements. This is a unique opportunity to be part of an emerging early-phase clinical company bringing innovative technology to the global market.

Key Responsibilities

• Lead the design, development, optimization, and execution of HPLC-based analytical methods (e.g., RP-HPLC, SEC, IEX) to support in-process, release, and stability testing.
• Develop, qualify, validate, and characterize GMP-compliant purity, SEC, and content methods for intermediates and drug products, with a strong emphasis on chromatographic workflows.
• Author and execute cGMP method qualification and validation protocols, prepare reports, and perform/oversee routine QC testing.
• Serve as Subject Matter Expert for chromatography methods during investigations of deviations, OOS/OOT events, assay failures, and other non-conformance issues.
• Provide technical leadership in HPLC troubleshooting, instrument maintenance coordination, data integrity practices, and chromatographic data review.
• Independently author method SOPs, analytical protocols, technical reports, and contribute to regulatory submissions.
• Maintain rigorous laboratory documentation and complete, audit-ready analytical records.
• Collaborate effectively with QC, Manufacturing, Process Development, and Regulatory teams to enable program success across phases.
• Thrive in a fast-paced, cross-functional environment with excellent communication and organizational skills.

Qualifications

• Ph.D. in Analytical Chemistry, Biochemistry, or related field with a minimum of 4 years (10 years for Senior Scientist) in the biotech/pharmaceutical industry; or M.S. with commensurate experience.
• Demonstrated in-depth expertise in HPLC, including method development, troubleshooting, system suitability design, chromatographic theory, and data interpretation.
• Hands-on experience with multiple chromatographic techniques (RP-HPLC, SEC, IEX, affinity, gradient optimization, detector setup/maintenance).
• Proven success developing and validating GMP analytical methods and supporting GMP operations.
• Experience with complementary analytical techniques such as UV-Vis, LC-MS, CE, ELISA, or other functional assays is beneficial.
• Experience working in a QC or cGMP laboratory environment with strong understanding of data integrity requirements (ALCOA+).
• Strong organizational skills, precision in documentation, and ability to manage multiple analytical workflows simultaneously.
• Excellent oral and written communication skills.
• 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 .

Under general supervision, enforces city/state ordinances governing citizen ownership of animals within the City; enforces regulations regarding stray, nuisance and dangerous animals; investigates reports of animal cruelty, abandonment and patrols assigned areas; collects and transports animals to the Shelter. This position receives direction from higher level police supervisory/management staff.
Position Snapshot: The Animal Services Officer (ASO) is another "face of the Fontana Police Department." This is a uniformed position that works a 10-hour shift, both in the field and in the office. While driving an assigned work vehicle, the incumbent will communicate via the in-car computer or radio during their shift to respond to and complete calls for service. ASOs assist citizens and officers after being trained in methods for interacting with an array of animals. ASOs are entrusted to work independently, within a team environment, and to communicate with the public in a productive manner. Writing detailed reports, testifying in court, and being on-call are all requirements of the position. This all makes for a fulfilling and exciting work experience that won't leave you bored or short of challenges.

Essential Functions

The incumbent must have the ability to:

• Patrol assigned areas of the City in City vehicle; capture wild, stray, and unlicensed animals for impounding; remove and transport dead and injured animals; under emergency conditions, destroy dangerous or grossly injured animals in the field using euthanasia procedures or arrange for proper destruction.
• Investigate complaints from the public and other agencies regarding animals that are stray, uncontrolled, abused, dangerous, wild or diseased; investigate animal bites, arrange for proper identification and quarantining; approve and monitor home quarantine of biting animals in accordance with regulations.
• Explain laws and regulations to the public relating to the care and control of animals, filing of complaints, and the operations and authorities of the animal shelter.
• Issue citations and warning notices for violations of applicable regulations; investigates problems through interviews and evidence collection; testifies in court regarding citations and monitors disposition of complaints.
• Assist other agencies and City departments in animal control and handling, including searches, evictions and other emergencies.
• Operate firearms, humane traps, mobile radios and related animal control tools, equipment and devices.
• Identify symptoms of common animal diseases and recommend medical care, isolation or destruction.
• Advise, counsel and instruct others in animal behavior and handling; may make educational presentations.
• Assist other Animal Control staff and City staff; instruct in field practices and animal care and handling procedures as needed.
• Communicate effectively, both orally and in writing.
• Prepare and submits investigative reports and daily activity reports; collect evidence on animal related cases; complete daily activity logs; and refer cases for prosecution given continued problems.
• Handle, capture and control animals humanely and effectively under stressful or emergency conditions.
• Safely operate assigned vehicles.
• Establish and maintain effective working relationships with those contacted in the course of work including the general public.
• Effectively operate computer hardware and related software.
• Perform any other tasks or functions deemed necessary to the daily operations of the employer.

A combination of experience and training that would likely provide the required knowledge and abilities is qualifying. The employee must have knowledge of:

• Proper animal-handling methods, techniques and equipment including methods for the capture of sick, injured or vicious animals.
• Basic species and breed identification for a variety of domestic and wild animals.
• Symptoms and behaviors associated with rabies and other common animal diseases.
• Approved euthanasia methods and procedures, including the use of controlled substances.
• State and City laws and regulations pertaining to the proper care and control of animals.
• Safe wok methods and safety regulations pertaining to animal control field operations.
• Record keeping methods and radio dispatch procedures.
• Appropriate procedures for the issuing of citations and testifying in court.

Successful candidates will be required to pass a drug screening, fingerprint screening, physical examination and a background investigation.

If you were referred to this position by a current Fontana Police Department employee, please use the link below to download the Applicant Referral Form. This form must be completed and submitted to the Human Resources Department at the time that your application is submitted. Submit completed forms to or to the Human Resources Office. Forms received after the position closes will not be accepted.
Click to download the Applicant Referral Form.

The City of Fontana has a flexible benefits plan. This plan allows for employees to select benefits based upon their individual needs. Full-time and Classified Part-time employees are eligible for benefits.

Please to view our excellent employee benefit options.

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Required Question

Description

The authorized level of the position is Account Clerk II. Applications are being accepted down to the Account Clerk I in the event of recruiting difficulties.

Salary Range:

Account Clerk I, SR-06: $3,141.00 per month

Account Clerk II, SR-08: $3,266.00 per month

Examples of Duties

* Verifies and enters details of costs, charges or other similar bookkeeping items to correct accounts or classifications;

* Receives, receipts and deposits cash collections of various kind, and maintains appropriate records; consults or studies specific books, manuals, catalogs or other sources in order to obtain desired information;

* Performs numerous types of computations such as discount, interest, ratio and percentage; determines rates, costs, amounts or other specifications for various types of items, selecting and using tables or classification data;

* Explains details of services, methods or policies; prepares requisitions or purchase orders, and may place orders for supplies, materials, equipment or contract services; processes invoices and may prepare vouchers for approval to authorize disbursement;

* May maintain inventory control records;

* Reviews the accounts clerical work of others, calling attention to use of incorrect procedures or methods and to incorrect entries or results;

* Composes correspondence requiring specific knowledge of methods, procedures, policies or other information; determines the general ledger accounts, journals and subsidiary accounts affected and the debit and/or credit entries to be made; summarizes transactions having a like effect and preparing control sheets or other posting documents reflecting the debit and/or credit entries to be made;

* Totals entries at specified intervals and takes a trial balance of debits and credits; determines corrective entries required to bring accounts into balance; closes and reconciles accounts;

* May supervise one or more lower-level account clerk or other subordinates.

Minimum Qualifications

Experience Requirement: Except for the substitutions provided in this specification, applicants must have had work experience of the kind and quality described below and in the amounts shown in the following table:

Class TitleGeneral Experience (years)Specialized Experience (years)Total (years) Account Clerk I1/201/2 Account Clerk II1/211-1/2

General Experience: Work experience which demonstrated knowledge of arithmetic and spelling and possession of the abilities to follow oral and written directions, to write simply and directly and to observe differences in words and numbers quickly and accurately.

Specialized Experience: Work involved in posting to accounting records and other systematizing of fiscal information; i.e., computing, classifying and recording numerical data to keep sets of financial accounting records complete and to derive reports therefrom. Such experience must have demonstrated knowledge of standard accounting classification and terminology pertinent to accounts maintenance operations and office practices and procedures relating to the processing and recording of transactions and accounting information.

Non-Qualifying Experience: Experience as an inventory clerk, stock clerk, supply clerk or other related work which is primarily concerned with posting non-fiscal data or checking accuracy of computations and which does not involve or require any fiscal record keeping knowledge is not considered qualifying specialized experience.

Substitution of Education for Experience:

* Graduation from high school with courses in basic English and arithmetic may be substituted for six (6) months of general experience.

* Successful completion of a substantially full-time equivalent accounting curriculum leading to a degree or diploma at an accredited business school, community college or other comparable institution which included accounting courses in double-entry procedures in analyzing, recording and summarizing transactions; and the preparation and interpretation of financial statements, may be substituted for specialized experience on the basis of one (1) year of such training for one (1) school year of experience, up to a maximum of two (2) years.

* Completion of one (1) school year of (more than one-year program) substantially full-time accounting curriculum which normally leads to a degree or diploma at an accredited business school, community college or other comparable institution which included accounting courses in double-entry procedures in analyzing, recording and summarizing transactions; and the preparation and interpretation of financial statements may be substituted for one (1) year of specialized experience.

* Education in an accredited university in a baccalaureate program may be substituted for specialized experience in the following basis:

a) A baccalaureate degree in accounting will be deemed to have met the

experience requirements for the Account Clerk V level.

b) Fifteen (15) semester hours of training may be substituted for six (6) months

of experience, up to a maximum of three and one-half (3-1/2) years provide

the training included at least three (3) credits per semester of accounting

courses such as accounting theory and methods used to record and report

financial information; analysis of methods for valuing the assets, liabilities, and

ownership; etc.

Supplemental Information

Salary: The advertised salary is based on full-time employment and includes shortage and school year differentials, if applicable.

Requirements: Applicants must meet all the requirements for the position they are seeking as of the date of the application, unless otherwise specified. Unless specifically indicated, the required education and experience may not be gained concurrently. Calculation of experience is based on full-time, 40-hour workweeks. Part-time experience is pro-rated. Example: Twelve months of experience at 20 hours/week is equivalent to six months of experience, not one year. Also, hours worked in excess of 40 hours/week will not be credited. Example: Twelve months of experience at 60 hours/week is equivalent to one year of experience, not one and a half years.

Temporary Assignment: Claims of Temporary Assignment (TA) experience to meet the minimum qualification requirements must be verified and attached to the application using one of the options below:

* A copy of the applicant's TA History Report or equivalent system-generated report;

* A signed letter from the applicant's supervisor that includes the applicant's name, his/her TA job title, the TA start and end dates (from mm/yy to mm/yy), his/her specific TA duties performed, and either the TA hours worked per week or total TA hours worked; or,

* Copies of the applicant's signed SF-10 Forms.

Documents: Attach all relevant supporting documents to your application. Documents that were attached to applications submitted before November 16, 2023 do not automatically attach or transfer to applications submitted on and after December 16, 2023. All submitted documents become the property of the Hawaii State Department of Education.

Information about Temporary Positions: Temporary positions may be extended year to year, dependent upon funding and departmental needs. Making yourself available for temporary positions increases your employment possibilities and may lead to permanent opportunities. A person hired for a temporary position may also become a temporary employee upon satisfactory completion of the initial probation period of at least six months. Once a temporary employee, you would be eligible to apply for promotion and transfer opportunities to permanent as well as other temporary positions. You may also enjoy other rights and benefits as afforded to an employee in a permanent position, with the exception of return rights and placement rights associated with a reduction-in-force.

Equal Opportunity

The Hawaii State Department of Education does not discriminate in its educational policies, programs, and activities on the basis of sex, race, color, religion, national origin, age, and disability in accordance with Title IX of the Education Amendments of 1972, Title VI of the Civil Rights Act of 1964, Section 504 of the Rehabilitation Act of 1973, Age Discrimination Act of 1975, and Americans with Disabilities Act of 1991. The Department does not discriminate in its employment policies, programs, and activities on the basis of sexual orientation, arrest and court record, and National Guard participation, as well as on the basis of sex, race, color, religion, national origin, age, and disability, in accordance with Title VII of the Civil Rights Act of 1964, Age Discrimination in Employment Act of 1967, Americans with Disabilities Act of 1991, Equal Pay Act of 1963, and Chapter 378, Part I, Hawaii Revised Statutes.

Payday

New employees can expect their first paycheck within the first 3 pay periods of their start date. Payday is on the 5th and 20th (or previous business day) of every month.

12-month civil service and SSP employees enjoy a range of competitive benefits:

* Holidays: You may be eligible for 13 paid holidays each year; 14 holidays during an election year.

* Vacation: Employees of Bargaining Units 1, 2, 3, 4, 9, 10 and 13 earn 21 days per year.

* Sick Leave: Employees of Bargaining Units 1, 2, 3, 4, 9, 10 and 13 earn 21 days per year. Accumulated (unused) credits may be used toward computing retirement benefits.

* Health Insurance: If eligible, the State pays a part of the premiums for each employee's enrollment in a State sponsored Medical, Drug, Vision, and Adult Dental Plan.

* Group Life Insurance: The State provides a free life insurance policy for employees and retirees.

* Premium Conversion Plan: Participating employees may increase their take-home pay by having the State deduct the cost of health care premiums before payroll taxes are withheld.

* Flexible Spending Accounts: Eligible employees can reduce their federal and state income taxes and social security taxes through a tax-savings benefit program called Island Flex. This program allows employees to set aside money from their paychecks to pay for out-of-pocket health care expenses and eligible dependent care expenses on a BEFORE-TAX basis.

* Retirement Plan: The State contributes to a retirement plan for eligible employees. Generally, employees with at least 10 years of credited service and who have reached 62 years of age or have 30 years of credited service and are 55 years old may retire and receive benefits.

* Tax Shelter Annuity (TSA): If eligible, Department employees are able to participate in a tax shelter annuity program. The TSA plan allows eligible employees to contribute pre-tax dollars to an employee-selected investment service provider authorized to provide TSA products.

* Deferred Compensation: The State offers employees a tax deferred (sheltered) retirement investment program. This program is an opportunity to build a retirement nest egg through voluntary payroll deductions. Several investment options are available.

* Temporary Disability Insurance: Qualified employees may be eligible to receive benefits for a disability caused by a non-work related injury or illness under this program.

* Social Security: As an employer, the State also contributes to an employee's social security account.

* Workers' Compensation: If an employee is injured while on the job, benefits covering medical expenses and partial wage support may be available through workers' compensation.

* Union & Collective Bargaining: Employees have the right to join the union for collective bargaining with the State and employee representation. Some employee unions provide discounts, insurance and other opportunities. Employees may also decide not to join a union, however, employees are required to pay union service fees unless the employee's job is excluded from collective bargaining.

The above is intended as a general summary of the benefits offered and is subject to change. This does not constitute a contract or binding agreement. Benefits vary by type of employment appointment and collective bargaining agreements.

01

GENERAL EXPERIENCE REQUIREMENT:

Do you possess at least six (6) months of general work experience which demonstrated knowledge of arithmetic and spelling and possession of the abilities to follow oral and written directions, to write simply and directly and to observe differences in words and numbers quickly and accurately; OR did you graduate from high school/GED with courses in basic English and arithmetic?

Note: Be sure to list your high school information in the Education section of your application.

* Yes

* No

02

SPECIALIZED EXPERIENCE REQUIREMENT:

Do you possess at least one (1) year of work experience involved in posting to accounting records and other systematizing of fiscal information; i.e., computing, classifying and recording numerical data to keep sets of financial accounting records complete and to derive reports therefrom?

Such experience must have demonstrated knowledge of standard accounting classification and terminology pertinent to accounts maintenance operations AND office practices and procedures relating to the processing and recording of transactions and accounting information.

* Yes

* No

03

SPECIALIZED EXPERIENCE REQUIREMENT (Cont.):

Starting with the most recent, list all employment periods you would like considered from the experience section of your application. Be sure to include the following:

A. Employer name; Dates of employment (from and to, month and year);

B. Your official job title; the number of hours worked per week;

C. List of job duties and the average number of hours per week performing each duty; and,

D. The name and title of your supervisor.

Note: Treat each employer/change in position separately.

If you do not have such work experience, please type \"None\" in the space provided.

04

DESCRIPTION OF DUTIES:

For each relevant employer/position, provide a detailed description of the duties you performed which demonstrate your knowledge of,

A. standard accounting classification and terminology pertinent to accounts maintenance operations; and,

B. office practices and procedures related to the processing and recording of transactions and accounting information.

Note: Use specific language that clearly describes the extent of your involvement and experience. Address each area separately. Do not copy/paste or give reference to your resume as a response to this question. If your write up is unclear, you may be asked to provide a copy of your official Job/Position Description.

If you do not have such experience, please type \"None\" in the space provided.

05

SUBSTITUTION OF EDUCATION FOR EXPERIENCE:

From the statements, select the option that BEST describes your highest level of education.

Note: You MUST provide a copy of your official transcripts from each institution to receive credit for the coursework.

* I have successfully completed an accounting curriculum and have received a degree or diploma at an accredited business school, community college, or other comparable institution. This program included accounting courses in double-entry procedures and the preparation and interpretation of financial statements.

* I have completed one year of a full time accounting curriculum leading to a degree or diploma at an accredited business school, community college, or other comparable institution which included accounting courses in double-entry procedures in analyzing, recording, and summarizing transactions; and the preparation and interpretation of financial statements.

* I don't have a Bachelor's degree in Accounting, but I do have completed Accounting courses in a baccalaureate degree program at an accredited university.

* I have a Bachelor's Degree in Accounting from an accredited university.

* I have none of the above.

06

TRANSCRIPTS, CERTIFICATIONS, AND OTHER VERIFYING DOCUMENTS:

Official or copies of official transcripts, certifications (front and back), and other verifying documents must be received in our office within ten (10) calendar days from the date of your application.

If these documents are NOT received by the deadline, your application may be rejected.

* I understand, and will submit the required documents to CSSP Recruitment within ten (10) calendar days.

* I understand, but I will not submit the required information. I understand that my application may be rejected.

* I have previously submitted my verifying documents for another recruitment.

Required Question

Employer Hawaii State Department of Education

Address P.O. Box 2360

Honolulu, Hawaii, 96804

Website

General Description:

Supervises staff and executes QC Biochemistry laboratory activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA/EU regulations, applicable International Regulations, processes and procedures. Establishes and implements QC Biochemistry procedures and supports regulatory compliance inspections. Ensures efficient and effective day to day operations of the Biochemistry laboratory.

Essential Functions of the job:

• Lead the QC Biochemistry GMP laboratory through late phase activities.
• Oversee QC Biochemistry laboratory related quality systems to ensure conformance with regulations and quality standards.
• Supervise a highly efficient QC Biochemistry team. Identify and develop key talents.
• Manage QC Biochemistry laboratory routine operations, including but not limited to validation, SOP revisions, specification updates, testing records, personnel training and, scheduling, etc.
• Execute laboratory bench work for analytical methods such as Potency assays, Binding ELISA, Cell Culture, Residual Host Cell Protein(HCP), Residual DNA as required.
• Ensure Biochemistry laboratory compliance with Environmental Health and Safety (EHS) standards.
• Ensure timely completion of testing (e.g., in-process, DS release, DP release, and stability testing) to ensure timely generation and reporting of test results In support of manufacturing operations.
• Ensure appropriate investigation of OOS events, discrepancies, lab errors, and equipment failures.
• Implementation of effective corrective actions and preventive actions (CAPAs).
• Participate in internal and external GMP audits where possible.
• Manage QC Biochemistry method transfers and method validation activities, including transfer/validation strategy and approval of protocols and reports.
• Ensure that the QC Biochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives.
• Manage, motivate, coach and mentor direct reports.
• Undertake any other duties as required.

Core Competencies, Knowledge, and Skill Requirements:

• Scientific degree (ideally in Biochemistry, molecular biology, biotechnology or related).
• Minimum of 5-7 years working experience and 2 years managing laboratory analysts in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required.
• Working knowledge and experience with Biochemistry analytical methods such as Potency assays, Binding ELISA, Cell Culture, Residual Host Cell Protein(HCP), Residual DNA as well as instruments such Incubators, Biosafety Cabinets, Plate Washers, and Microplate Readers, etc.
• Knowledgeable with USP/EP and cGMP/EU GMP regulations.
• Direct experience in a GMP quality control lab is a must.
• Familiar with instrument and equipment validation.
• Expert knowledge of quality control principles, practices, and standards for the biopharmaceutical industry.
• Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
• Credible and confident communicator (written and verbal) at all levels.
• Strong analytical and problem-solving ability.
• Excellent project management skills.
• Hands-on approach, with a ‘can do’ attitude.
• Ability to prioritize, demonstrating good time management skills.
• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
• Self-motivated, with the ability to work proactively using own initiative.
• Committed to learning and development.

Supervisory Responsibilities:

• Supervise a highly efficient QC Biochemistry team. Identify and develop key talents.
• Manage QC Biochemistry laboratory routine operations, including but not limited to validation, SOP revisions, specification updates, testing records, personnel training and scheduling, etc.
• Manage QC Biochemistry method transfers and method validation activities, including transfer/validation strategy and approval of protocols and reports.
• Ensure that the QC Biochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives.
• Manage, motivate, coach and mentor direct reports.

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.

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.

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

The Sr. Manager, QC Microbiology, is an exempt level position with responsibilities for managing the operation and workflow of the quality control microbiology laboratories in support of cell therapy manufacturing. This includes hiring, development and performance management of staff, reviewing/approving laboratory test data, developing and implementing microbiology procedures and methods, supporting laboratory investigations and ownership of various QC microbiology department projects. The role develops and implements long-term strategies and manages a team of people leaders and technical professionals within the QC department based on assigned work, direction, coaching and developing capabilities

• Ensuring adequate training (skills-based, cGMP and safety) of people leaders and associates within the department.
• Manage Raw material, in-process, environmental monitoring/utility, product release, and stability testing.
• Manage and support Investigation of laboratory non-conformances (events, deviations, and invalid assays).
• Maintenance, calibration and qualification of laboratory instruments and equipment.
• Test method verification, qualification, validation and/or transfer activities in the QC Micro laboratories.
• Process Performance Qualification and Continued Process Verification activities associated with QC microbiology laboratory testing.
• Providing expertise in troubleshooting complex laboratory issues and demonstrating strong reasoning skills in support of ongoing laboratory investigations.
• Maintain detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in on-the-job training requirements.
• Collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering and Maintenance to support business needs.
• Contribute to global strategies related to QC laboratories which align with compliance and business objectives as well as the overall corporate vision.
• Manage departmental budget and resources; prepare staffing plans. Make adjustments to roles and responsibilities of department to meet business needs.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Monitor QC method performance through trending analysis for on QC generated test results.
• Represent department during internal and external audits.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
• Works in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, Technical Operations, Engineering and Maintenance, Supply Chain and Planning.
• Other duties will be assigned, as necessary.
  

• A minimum of a Bachelor’s Degree in Science, Biology or equivalent technical discipline is required.
• A Minimum of 12 to 14 years relevant work experience is required. It is preferable that the candidate has experience working in an aseptic manufacturing facility, preferably in microbiology quality control laboratory, quality assurance, or cell therapy. A minimum of 3-5 years of leadership experience is also required.
• Experience working with Quality systems is required.
• Extensive knowledge of chemical, biochemical and microbiological concepts is required.
• Ability to apply basic and advanced mathematical concepts (including statistics) in the evaluation of laboratory data is required.
• Knowledge of cGMP regulations and FDA/EU guidance is required.
• Comfortable with speaking and interacting with inspectors.
• Good written and verbal communication skills are required.
• This position may require up to 10% domestic or international travel as business demands.
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
• Proven people management and leadership experience are required.
• In-depth knowledge and experience in biopharmaceutical analysis method verification is preferred.
• Experience in microbiological test methods and EM is preferred.
• Ability to quickly process complex information and often make critical decisions with limited information.
• Ability to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities.
• Proficient in applying excellence tools and methodologies.
• Ability to summarize and present results, and experience with team-based collaborations is a requirement.
• Experience in developing and setting long-term objectives for individual and teams.
• Have a high sense of responsibility and professionalism with excellent organizational skills, analytical judgment and communication skills.
• Able to work cross functionally and under pressure.
  
  

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay): : $142,146 USD - $186,567 USD

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.