Caltech Transfer Jobs in Usa

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• Manage customer accounts on a personal basis that include resolving problems, providing customers with information and assistance regarding investment management, statements of accounts, taxes, and remittances.
  
• Direct the Trust Operations Department regarding daily account transactions such as wire and cash transfers, ACH disbursements, bill paying, and the opening and closing of accounts.
  
• Monitor transactions for completion and accuracy.
  
• Coordinate investment transactions with the Investment Department including but not limited to monitoring cash balances daily for purchases, transferring sales proceeds to money market accounts and following up on client's requests for purchases, sales or gifting.
  
• Coordinate the transfer of incoming assets to new or existing accounts, as well as the transfer of outgoing assets for terminating accounts.
  
• Prepare correspondence, Excel spreadsheets (i.e., miscellaneous reports for client budget worksheets, income projections and gifting schedules), assist with the production of PowerPoint presentations, and marketing materials.
  
• Coordinate and prepare tax-related payments information with clients and outside professionals.
  
• Provide information to Fiduciary Officers for client meetings.
  
• Organize with Fiduciary Officers to maintain client, beneficiary and advisor information in client files and account records on database management and trust accounting systems, assist with contact management input, sales, expense, and other internal reports.
  
• Keeps abreast of new regulations relative to trust administration and legal and tax consequences of investment decisions and strategies.
  
• Participate in community and business activities to enhance the image and position of the Bank and to develop new business for the trust department.
  
• Uphold Nicolet's philosophy and policies by maintaining appropriate controls to ensure full compliance with applicable laws and regulations, thereby fulfilling legal responsibilities and enhancing the quality of services provided by Nicolet.
  
• Understand and communicate the value of diversity within the workplace and to work successfully with others without regard to age, gender, race, sexual orientation, ethnicity, culture, religion, disability status, socioeconomic status, or other non-job-related classification, including a commitment to Nicolet's policies on equal employment opportunities and non-discrimination with a willingness to pursue efforts of inclusion and respect toward different perspectives.
  
• Performs all other duties as assigned.
  

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• Bachelor Degree in Finance or Business and/or equivalent experience in a financial institution or brokerage house.
  
• 3+ year's personal trust relationship management or related experience.
  
• Certified Trust and Financial Advisor (CTFA) certification or marked progress towards achieving and ability to attain within 2 years of employment.
  
• Client-centered focus with excellent strategic thinking and consultative skills.
  
• Strong organizational, multi-tasking and prioritizing skills.
  
• PC, phone system, general office equipment.
  
• Proficiency with Microsoft Office applications.
  
• Ability to maintain strict confidentiality.
  
• Ability to effectively promote Nicolet as bank of choice.
  
• Self-motivated and resourceful.
  

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• Medical, Dental, Vision, & Life Insurance
  
• 401(k) with a company match
  
• PT0 & 11 1/2 Paid Holidays
  

The Freight Coordinator position's primary responsibility is to fulfill our mission statement, \"to create the most enjoyable shopping experience possible for our Guests.\" Additionally, the Freight Coordinator performs a variety of operational tasks assigned by store management (e.g. receiving and unpacking of daily shipments, shipping merchandise, backroom maintenance, and routine cleaning of facilities).

Essential Duties and Responsibilities This description intends to describe the general nature and level of work performed by Teammates assigned to this job. It is not intended to include all duties, responsibilities and qualifications. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Sales Generation and Guest Service

• Compare and verify merchandise invoices to items received to ensure that shipments are correct
• Send any alterations, layaways, or special orders to Guests via FedEx
• Check accuracy of freight packing slips and transfer slips
• Double-check that all transfers have been processed through the register and that items match what you are shipping out
• When shipping items to Guests and other stores, must fold items and place in appropriate sized box for proper presentation of product when unpacked

Visual Merchandise Management

• Remove any pins and plastic from merchandise shipped in
• Place Sensormatic tags on each garment in the designated place
• Hang and fold merchandise to be put on the sales floor and steam when necessary
• Assist on projects on floor when necessary

Operations

• Ability to work a flexible schedule, which may include mornings, evenings, and weekends, and the day of/day after Thanksgiving and Christmas, based upon store and business needs
• Develop and maintain knowledge of Point of Sale (\"POS\") software
• Receive freight boxes and store transfers through register
• Send discrepancies in store mail and file non-errors for 30 days
• Maintain all shipment-related paperwork
• Watch for and recognize security risks and thefts, and know how to prevent or handle these situations
• Make FedEx labels for all packages being sent out and sort packages by required shipment transit time (expedited shipping or regular ground shipping)
• Send in recalls and Return to Vendors (RTVs) on a weekly basis
• Keep supplies in stock and organized (e.g. boxes, transfer bags, printer paper, hangers, sensors, etc.)
• Organize fixtures and shelving
• Engage in activities that support a neat, clean, and organized work area.
• Maintain daily work filed and in order
• Communicate any policy violations to Store Manager, District Manager, and/or Human Resources in a timely, confidential manner
• Provide feedback to Store Manager, Assistant Manager, and Floor Leaders regarding merchandise handling concerns
• Understand and apply the Buckle's Code of Ethics and all Buckle's policies, procedures, and handbooks.
• Fulfill mission statement by performing job duties with a high level of customer service while contributing to a positive team spirit.
• Special projects and other duties as assigned.

Supervisory Responsibilities

This job has no supervisory responsibilities.

Part-time Benefits

Benefits Available (after applicable waiting period):

• Teammate Discount
• Performance Bonuses
• Employee Assistance Program
• 401(k) (subject to additional requirements)
• Paid Sick Time (where required by state)

Education and/or Experience

No prior experience or training.

Additional Requirements

Due to the nature of the job, must be 18 years of age or older.

Physical Demands

The physical demands described here are representative of those that must be met by a Teammate to successfully perform 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 Teammate is regularly required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance and jump; stoop, kneel, crouch, or crawl and talk or hear. The Teammate is occasionally required to sit. Physical ability to lift and maneuver 50 lbs throughout the store and backroom. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Work Environment

While performing the duties of this job, the Teammate regularly works in a retail store setting. The noise level in the work environment is usually moderate.

Equal Employment Opportunity Buckle is committed to hiring and developing the most qualified Teammates from the available workforce in the communities we serve. Equal employment opportunity has been, and will continue to be, a fundamental principle at Buckle, where employment is based upon personal capabilities and qualifications without discrimination and retaliation because of veteran status, uniformed service member status, race, color, national origin or ancestry, creed, religion, sex, sexual orientation, gender identity or expression, age, pregnancy (including childbirth, lactation, and related medical conditions), national origin or ancestry, physical or mental disability, genetic information (including characteristics and testing), or any other protected characteristic as established by applicable local, state, or federal law. For state specific information, refer to the Teammate Center.

Under the leadership of the Assistant General Manager, Operations (AGMO), the Specialized Operations Associate Supervisor is responsible for leading, training and supervising the daily operations of the General Office, Jewelry Department, and the Returns Desk (select locations), including tracking and maintaining financial reporting.

• Lead and coordinate the opening of the store: safe, controller, registers and distribution of reports
• Supervise SOA team is maintaining daily functions, including but not limited to; morning cash entry, processing bank deposits, reconciling chargebacks, and counting register and petty cash
• Act as escalation specialist in resolving customer issues, both internal and external

• Follows and trains Jewelry Standards and Shipping Guidelines, makes recommendations to improve processes and maintains inventory accuracy.
• Receives, verifies, and ensures the proper booking of all jewelry in accordance with Company standards
• Supervises the efficient processing of re-tickets, RTV's, Transfers, Advanced Shipping Notice (ASN) Shipments and price changes
• Oversee the retrieval and processing of all merchandise to be returned/transferred to the vendor in accordance with Company standards
• Ensure case counts are completed, all merchandise is entered into the case count system after receipt, and all discrepancies are reconciled
• Maintain and audit the repair log, track all repairs sent to the vendor or local shop, and submit repair invoices
• Receive and verify all merchandise for trunk shows, assist in show set-up/take down, recap results, and manage the consignment merchandise life-cycle
• Ensure SOA team prepares and submits all special order requests
• Process and oversee Jewelry fulfillment

• Resolves customer issues, ensure team provides customer service to all clients returning product, oversee associate scheduling, maintain product organization, create, pack and manifest transfers, and galvanize a return transfer compliance of 95%+

• Internal Audit readiness and adherence to Internal Audit standards, including but not limited to monitoring vault/safe contents to remain up-to-date (audit ready)
• Supporting the AGMO and corporate team with cross-functional training of specialized operations team,
• Assist in the implementation of policies and best practices, makes recommendations to Management team
• Proactively partner with AGMO and corporate team on weekly/monthly workload
• Motivate team to meet results; make recommendations to Management for hiring, firing and promotion decisions
• Assist managers and associates on the selling floor as necessary
• Following up on reporting, outstanding invoices, and escalated issues to resolve

• Ability to drive profitability through execution of SOA KPIs
• Comfortable with real-time coaching, working closely with Associates, Store Leadership and cross functional Corporate partners
• Ability to work well in a fast-paced, team oriented environment that requires a high degree of multi-tasking with minimal supervision
• Ability to work a flexible schedule as per business needs & adheres to Dependability standards Demonstrates attention to detail and keeps personal work space organized
• Ability to influence team to follow store policies & procedures to help in decision-making
• Verbal and written communication skills; handles telephone and face to face interactions effectively and professionally
• Maintains confidentiality when handling issues
• Other store initiatives as assigned by management
• Ability to lift cartons (up to 50lbs), climb ladders, and handle racks and carts of merchandise.
• Must have strong computer skills, i.e. Google, MS Office, and adapt to changing technology

• Be part of a world-class team; work with an adventurous spirit; think and act like an owner-operator!
• Exposure to rewarding career advancement opportunities, from retail to supply chain, to digital or corporate.
• A culture that promotes a healthy, fulfilling work/life balance
• Benefits package for all eligible full-time (including medical, vision and dental).
• An amazing discount

The starting rate for this position is between $50,963.31 - $55,000.00 annually. Factors which may affect starting pay within this range may include market, skills, experience and other qualifications of the successful candidate.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, basic life insurance, supplemental life insurance, disability insurance, and a variety of additional voluntary benefits (such as critical illness, hospital and accident insurance).

COME JOIN AN AMAZING TEAM! WE WANT TO OFFER YOU A CAREER, NOT JUST A JOB! Stevens Equipment Supply, a member of Daikin Industries Inc., is a wholesale distributor of equipment, parts, and supplies, is seeking a professional, skilled individual for our Local Delivery Driver to join our team at our New Berlin, WI branch. The Driver is responsible for the safe operation of company trucks for timely delivery of products to customer and company locations. The driver will safely load, unload, and transfer products as needed utilizing various equipment and forklifts within the branch location, trucks/trailers and sites. The driver will need to have effective and high-quality customer service skills as well as assist the branch/warehouse operations.

Why work with us?

* Benefits are effective on day one for all full-time direct hires

* Training programs are available to help guide team members and develop new skills

* Growth Opportunities - there is immense opportunities to grow your career

* You will be part of a Global Company - our family brands are backed by Daikin Industries, Ltd.

Responsibilities may include:

* Load, unload and deliver products to customer sites within designated time frames safely using the most efficient routes possible.

* Maintain required logs and reports necessary to maintain compliance with DOT and Company policies relating to safety standards and operation of delivery vehicles, forklifts etc.

* Safely load and properly block, brace, and secure the cargo.

* Strong knowledge of driving/traffic and transportation laws, regulations and ensure continuous compliance while operating the truck(s).

* Operate forklift safely and efficiently to transfer, load, unload product - ensure accurate product and quantity of product is being loaded into customer.

* Perform pre-check and post-check operations of Company vehicles and forklifts per required procedures.

* Perform warehouse duties and ensure accurate product and quantity of product is being loaded / transferred for customers.

* Notify the manager immediately of any accidents, damage, violations, and areas of concerns to implement corrective measures and/or actions.

* Follow good housekeeping and safety practices at all times.

* Act as the warehouse and/or front counter back up as needed.

* Perform additional projects/duties to support ongoing business needs

Knowledge & Skills:

* Safe driving skills: proven abilities to safely operate a flat bed or box truck.

* Must meet and pass DOT standards.

* Ability to successfully pass forklift training and delivery truck driving tests through our Prove it Pass it training within 30 working days of start date.

* Ability to safely operate a forklift as needed.

* Ability to safely load/transfer products to designated locations in a timely manner without causing damage.

* High level of attention to detail and surroundings

* Ability to follow all policies and established practices for branch, driving and warehouse operations.

* Ability to apply good judgement, strong work ethics and integrity on the job.

* Must be compliant and results oriented.

* Be dependable, work well in a team environment, and establish positive working relationships with employees and customers.

* Effective verbal and written communication skills

* Basic Computer skills include data entry to process transactions and generate reports and orders.

* Able to multi-task well with the ability to assist in warehouse or front counter or a branch as needed.

* Must be reliable and dependable; and able to work assigned hours and days

Experience:

* 2 plus consecutive years of driving a commercial vehicle

* Current Valid Driver License with excellent driving record

* 2 plus years of warehouse / logistics experience is a plus

Education:

* High school diploma or equivalent (for example GED)

* Previous training on operating forklifts and delivery trucks is highly preferred

Physical Requirements/Work Environment:

* Must be able to perform essential responsibilities with or without reasonable accommodations.

* DOT screening annually.

Qualified Applicants must be legally authorized for employment in the United States. Qualified applicants will not require employer sponsored work authorization now or in the future for employment in the United States.

The Company provides equal employment opportunity to all employees and applicants regardless of a person's race, color, religion (including religious dress or grooming practices), creed, national origin (including language use restrictions), citizenship, uniform service member or veteran status, ancestry, disability, physical or mental disability (including HIV/AIDS), medical condition (including cancer and genetic characteristics), genetic information, request for protected leave, marital status, sex, pregnancy, age (over 40), sexual orientation, gender, gender identity or expression, political affiliation, or any other characteristic protected by law. The Company will comply with all federal and state regulations and statutes pertaining to individuals with disabilities.

#IND123

Job ID: 372358

Practice area:- Estate & Tax Planning,Probate

Estate Planning & Probate Associate Attorney (2–6 Years Experience) – Private Client Services | Boston, Massachusetts

Keywords:- Estate Planning Associate Attorney, Trusts and Estates Attorney, Probate Attorney, Estate Planning Attorney Boston, Estate and Tax Planning Attorney, Boston legal jobs, Attorney jobs Boston MA, MA Bar required, Law firm estate planning associate, Partner-track position, lawyer,estate planning, gift tax, generation-skipping, dynasty trust, GRAT, QTIP trust, charitable trust, family wealth planning

The firm, established in 2000, represents clients including families, individuals, and industries. Its service areas include executive leadership, residential real estate, commercial real estate, commercial lending, estate planning, dispute resolution, tort defense, litigation, and hospitality and recreation. It has offices in Boston, Andover, and Waltham, Massachusetts, and Nashua, New Hampshire. Three of its attorneys have been selected to the lists of Super Lawyers and Rising Stars by Super Lawyers publication.

A respected law firm is seeking an Estate Planning & Probate Associate Attorney (2–6 years experience) to join its growing private client services practice in Boston, Massachusetts. This Estate Planning Attorney role focuses on advising individuals, families, and fiduciaries on sophisticated estate planning and wealth preservation strategies.

Attorneys pursuing Boston legal jobs in private client services will gain the opportunity to work on complex estate planning matters, including wealth transfer strategies, trust administration, and tax-efficient asset structuring. The Estate Planning Attorney will collaborate closely with financial advisors, accountants, and fiduciaries to provide comprehensive planning solutions.

This partner-track position provides significant opportunities for professional growth, client development, and leadership within a dynamic estate planning practice. Attorneys with an existing book of business are particularly encouraged to apply.

This opportunity is actively interviewing candidates seeking advanced Boston legal jobs in estate planning and probate law.

________________________________________

Key Responsibilities

• Advise individuals, families, and fiduciaries on estate planning strategies, wealth preservation, and generational wealth transfer.

• Draft sophisticated estate planning documents including wills, trusts, powers of attorney, and healthcare directives.

• Provide legal guidance on estate, gift, and generation-skipping transfer tax strategies.

• Assist clients with charitable planning and business succession strategies.

• Support probate and estate administration, including fiduciary guidance, tax filings, and asset distributions.

• Collaborate with financial advisors, accountants, and other professionals to create integrated estate planning solutions.

• Maintain and expand client relationships while contributing to practice growth.

• Utilize an existing book of business to support business development and client portfolio expansion.

________________________________________

Qualifications

• Juris Doctor (JD) from a recognized law school.

• Massachusetts Bar required and active license to practice law in Massachusetts.

• 2–6 years of experience practicing as an Estate Planning Attorney or trusts and estates associate.

• Experience handling estate planning, trust administration, and probate matters.

• Demonstrated book of business preferred.

• Strong drafting skills for complex estate planning documents.

• Ability to manage client relationships and develop business opportunities.

• Strong legal writing and analytical abilities.

________________________________________

Education

• Juris Doctor (J.D.) degree from an accredited law school.

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Certifications

• Licensed to practice law in Massachusetts.

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Skills

• Strong technical knowledge of estate, gift, and generation-skipping transfer tax laws.

• Advanced drafting abilities for trusts, wills, and estate planning instruments.

• Excellent written and verbal communication skills.

• Strong client relationship management and advisory abilities.

• Ability to work independently while contributing to a collaborative team environment.

________________________________________

Culture & Firm Appeal

This opportunity is with a well-established law firm serving families, individuals, and businesses throughout the Boston legal community. The firm provides a broad range of legal services while maintaining a strong reputation for personalized client service and practical legal solutions.

Attorneys benefit from a collaborative environment where private client attorneys work closely with professionals across multiple disciplines. The firm encourages entrepreneurial attorneys to develop client relationships and expand their professional networks.

Professionals exploring Boston legal jobs in estate planning will appreciate the firm’s emphasis on business development, client-focused service, and long-term career growth.

The firm also maintains a strong reputation within the regional legal market and has attorneys recognized by respected industry publications.

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Why This Role Is Unique

• Opportunity to advise high-net-worth individuals and families on advanced estate planning strategies.

• Meaningful involvement in wealth preservation, tax planning, and succession planning matters.

• Opportunity to grow and expand a private client practice through business development.

• Collaborative team environment with experienced estate planning professionals.

• Partner-track position supporting long-term professional advancement.

• Ideal opportunity for attorneys seeking advanced Boston legal jobs in estate planning and probate law.

This position rarely opens at this level and provides a strong opportunity for attorneys to grow a successful private client services practice within a respected legal environment.

________________________________________

Call to Action

Apply now for a confidential discussion with a BCG Attorney Search recruiter.

Explore this elite-level opportunity today.

Submit your resume to learn more about this prestigious role.

________________________________________

BCG Attorney Search is the industry leader for placing candidates in permanent positions in law firms. Since 2000, our recruiters have placed several thousand attorneys and enjoyed extraordinarily high success rates with our candidates. As a BCG Attorney Search candidate, you have access to more opportunities than any legal placement firm in the United States. We are able to offer the most in-depth insight in the legal recruiting market thanks to our dedicated team of over 150 employees who mercilessly research, study and analyze the legal market. The depth and breadth of our research empowers us to place attorneys at rates that are unparalleled at any placement firm in the United States. Many of our recruiters make 30 to 40 placements per year, while recruiters at competitor firms are likely to make four or five. Unlike other placement firms that can only tell you about openings at major AmLaw firms, we place candidates of all backgrounds in firms of all sizes. While other legal recruiters only represent a narrow band of candidates from top law firms and top law schools, our research, firm contacts, and market insight allow us to place hundreds of candidates each year who do not fit this mold. It is rare that we do not get candidates we represent interviews and offers. No one in the world is better at legal recruiting and placement than BCG Attorney Search.

BCG Attorney Search will confidentially review your application and will not forward your materials to the firm without first discussing the opportunity with you.

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.

Job Title: Director Process Development and Manufacturing, CMC

Department: CMC

Reports to: Chief Technical Officer

About the Company:  

Opus Genetics is committed to building an innovative, efficient and sustainable science based and commercial ophthalmic biopharmaceutical company leading the development of transformative gene therapies for the treatment of inherited retinal diseases (IRDs) and therapies to treat patients with other retinal and refractive disorders.

Job Summary: 

The Director of Process Development and Manufacturing will be the technical lead for development and manufacturing of assigned assets within the Opus gene therapy programs focusing on technical transfer and process development and execution supporting product development and manufacturing to achieve company goals and strategies. This includes working collaboratively with external partners (i.e. CDMOs, contract labs, suppliers) to develop technical studies, analyze complex data, make data driven decisions, and author, review, and approve technical and regulatory documents. The ideal candidate will have a deep technical understanding of AAV gene therapy upstream and downstream development and process optimization.  This role will directly interact with the CDMO/contract partners and be responsible for building and maintaining excellent working relationships. Knowledge of manufacturing platforms, consistent with AAV technology, at scales ranging from process development through GMP and PPQ activities. The candidate will be hands-on and expected to provide content to all these areas. 

Duties/Responsibilities: 

·      Work with Opus CDMO/contract manufacturing and laboratory partners to develop a phase appropriate robust manufacturing program to support the process development and engineering of pre commercial and commercial cGMP material to support pre-clinical studies, clinical trials, and commercial supply. 

·      Support, author, and review/approve manufacturing plans and documentation including technical transfer, batch records and documentation, product specifications, stability programs, bridging and comparability studies, and other reports utilizing phase appropriate QbD best practices.

·      Support, author, and review/approve manufacturing documentation including testing records, certificates of testing/analysis, campaign summary reports, investigations, etc. 

·      Support, author, and review/approve regulatory documentation including pINDs, INDs, agency responses, CMC meeting requests and briefing packages, and BLAs.   

·      Ensure proper reference standard material is in place, tested, and released for each product. Lead technology transfer between sites. 

·      Ensure regulatory requirements are in place to support manufacturing campaigns with respect to Master Cell Banks, Plasmids, Drug Substances, Drug Products, and Diluents, to prevent developmental delays and or interruptions to clinical programs or regulatory filings.

·      Perform the role of person in plant as needed at the Opus CDMO/contract manufacturing partner’s sites. Act as the CMC expert during audits and interactions with regulatory agencies. 

·      Manage work to project plans for multiple gene therapy programs in the preclinical, pre-IND, IND/clinical, and commercial stages. 

·      Identify and lead the resolution of operational and functional level challenges, work with program and/or function managers to escalate issues to senior management.

·       Hands on resolution to issues/content generation. Design effective and high-quality presentations and progress reports, as requested.

Supervisory Responsibilities: 

·      None 

Education and Experience: 

·      Master’s degree (minimum) from an accredited institution in a science or health-related field with minimum of 7-10 years of experience in the pharmaceutical or biotechnology industry. Ophthalmology experience is preferred.

·      Additionally, a minimum of 5 years of direct manufacturing experience for biopharmaceuticals. Preference will be given for direct AAV gene therapy experience. Previous CDMO/contract lab experience also preferred.

·      Experience designing and executing technical transfer and scale up campaigns and associated documentation.

·      Experience in writing and reviewing regulatory submissions including pINDs, INDs, Meeting Requests/Briefing Packages, Annual Report/DSUR’s, and BLAs. 

·      Experience with FDA and/or other regulatory agency requirements and interactions.

·      Strong skill set in interacting with multidisciplinary teams for preclinical and clinical development. Clear understanding of the drug development process with experience in multiple phases.

·      Experience with Orphan/Rare Disease programs, and/or Fast Track/Breakthrough Therapy is a plus.

·      Demonstrated leadership skills and ability to influence across all levels of a cross-functional team without direct managerial authority. Experience in risk assessment, negotiation, and problem solving/mitigation.

·      Outstanding interpersonal skills, ability to communicate effectively in both oral and written form, with effective time management skills needed to manage multiple ongoing projects simultaneously.

·      Demonstrated advanced computer software proficiency (Word, Excel, Smartsheet’s, PowerPoint, etc.).  

Physical Requirements:  

·      Ability to travel 20% of time

·      Ability to work in laboratory settings/situations

·      Prolonged periods sitting at a desk and working on a computer. 

·      Must be able to lift up to 15 pounds at times. 

Location:

This position is currently based in the Durham North Carolina area; Hybrid/ remote options considered.

 Salary Range:

$190,000-210,000

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor. 

Opus Genetics is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. 

HCLTech is looking for a highly talented and self- motivated Design Quality Engineer to join it in advancing the technological world through innovation and creativity.

Job Title: Design Quality Engineer

Job ID: 78923

Position Type: Full-time with HCLTech

Location: Palm Beach Gardens, Florida

Role/Responsibilities:

Summary

The Design Quality Engineer will act as the quality representative and design control lead on cross-functional new product development (NPD) and sustaining engineering teams. This role ensures that orthopedic implants and associated instrumentation are developed and manufactured in compliance with internal QMS, FDA 21 CFR 820, ISO 13485, and ISO 14971 standards. The ideal candidate will facilitate risk management activities, verify design outputs, and ensure a smooth design transfer to manufacturing

Key Responsibilities

• Design Control Leadership: Lead and support Design Control activities (planning, design inputs, outputs, verification, validation, and design transfer) across the product lifecycle.
• Risk Management: Facilitate and lead risk management activities, including development of Risk Management Plans, Hazard Analysis, and Design Failure Mode Effects Analysis (DFMEA) for orthopedic products.
• Verification & Validation (V&V): Approve design verification/validation plans, protocols, and reports to ensure compliance with product requirements, including mechanical testing, tolerance analysis, and anatomical lab testing.
• Design Transfer: Ensure the successful transfer of new products to production by assisting in process validation requirements (IQ/OQ/PQ) and reviewing manufacturing documentation.
• Technical Documentation & Audits: Review and approve Design History Files (DHF) and Device Master Records (DMR) for conformance. Support internal and 3rd party audits (FDA/Notified Body).
• Post-Market Surveillance (PMS): Utilize post-market data and analytics to report on product performance in the field, providing feedback to R&D for continuous improvement.
• Root Cause Analysis: Lead quality-related problem-solving and root cause investigations for design-related issues, complaints, and CAPAs.
• Regulations: Strong understanding of FDA 21 CFR 820, ISO 13485, and ISO 14971.
• Technical Skills: Knowledge of Geometric Dimensioning and Tolerancing (GD&T) and machining methodologies (titanium and stainless steel).
• Tools: Proficient in statistical software tools (e.g., Minitab) for data analysis and risk analysis.

Preferred Skills

• Certified Quality Engineer (CQE), Certified Six Sigma Green/Black Belt.
• Experience with EU MDR regulatory submissions.
• Experience with surgical instrumentation and/or implantable devices.

Core Competencies

• Strong analytical, problem-solving, and critical thinking skills.
• Effective communication and interpersonal skills to work within multi-disciplinary, cross-functional teams.
• Detail-oriented with a focus on compliance and accuracy.

Pay and Benefits

Pay Range Minimum: $38.46 per hour

Pay Range Maximum: $47.00 per hour

HCL is an equal opportunity employer, committed to providing equal employment opportunities to all applicants and employees regardless of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical disability or genetic information, military or veteran status, or any other protected classification, in accordance with federal, state, and/or local law. Should any applicant have concerns about discrimination in the hiring process, they should provide a detailed report of those concerns to for investigation.

Compensation and Benefits

A candidate’s pay within the range will depend on their work location, skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year.

How You’ll Grow

At HCLTech, we offer continuous opportunities for you to find your spark and grow with us. We want you to be happy and satisfied with your role and to really learn what type of work sparks your brilliance the best. Throughout your time with us, we offer transparent communication with senior-level employees, learning and career development programs at every level, and opportunities to experiment in different roles or even pivot industries. We believe that you should be in control of your career with unlimited opportunities to find the role that fits you best.

Ensera is growing, and we’re looking for a Director, Product Industrialisation to help bridge Design & Development with Manufacturing—ensuring new products move smoothly, safely, and compliantly from concept to commercial scale.

In this role, you will lead Design Transfer, drive DFM/DFA/DFX from the earliest stages, and build robust, validated manufacturing processes (IQ/OQ/PQ). You’ll shape factory readiness, partner closely with Supply Chain and QA/RA, and support safe, high‑quality, cost‑effective production in line with ISO 13485, FDA QMSR and EU MDR. We are open to hybrid, working from different countries based on the role needs.

We’re seeking a collaborative leader who can translate complex technical challenges into scalable manufacturing solutions, while fostering a culture built on safety, inclusion, and our values: Find a Way, Care, and Pull Together.

What You’ll Do

• Lead Design Transfer and New Product Introduction across cross‑functional teams and support design and product development in providing manufacturable product solutions.
• Apply DFM/DFA/DFX principles to ensure scalable, compliant manufacturing.
• Oversee process development and validation (IQ/OQ/PQ).
• Drive equipment, automation, and tooling strategies, including injection molding and advanced assembly.
• Lead risk management activities (PFMEA) and champion quality and SHE standards.
• Build strong partnerships across Operations, R&D, Supply Chain, QA/RA, and customer teams.

What You Bring

• Significant experience (typically 10+ years) in regulated medical device, pharma, diagnostics, or related manufacturing environments.
• Proven leadership in NPI, Industrialisation, and Design Transfer.
• Strong knowledge of ISO 13485, FDA regulations (21 CFR 820 / QMSR), and EU MDR.
• Expertise in process validation, risk management, and advanced manufacturing technologies.
• Inclusive leadership style with the ability to influence and collaborate across functions.

Why Ensera

• Opportunity to shape an Industrialisation Centre of Excellence.
• Inclusive, safety‑first culture where every voice is valued.
• Professional development pathways and competitive rewards.
• Salary range will be shared in line with EU Pay Transparency requirements.

How to Apply

Interested? Please send your CV and a short note on a recent NPI or Design Transfer project you’ve led to

Ensera is an equal opportunity employer. We welcome applicants from all backgrounds and provide reasonable accommodations at every stage of the recruitment process.

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