Schott Pharma Jobs in Usa

Position Summary

We are seeking a dynamic individual to manage the day-to-day operations in a Biotech environment. This is an exciting and unique opportunity to support our Pharmaceutical Development team’s office and lab space. The successful candidate will be able to thrive in a fast-paced, ever-changing environment, and manage competing priorities, while maintaining a professional demeanor with employees.

In this critical role, you will serve as the primary interface between our company and its service providers, vendors, and consultants. This position requires great attention to detail, organization, and professionalism, and the ability to maintain an efficient business environment.

Responsibilities, including but not limited to:

·Ensure smooth daily operations of the office environment, making sure employees have a clean and safe office.

·Greet and check in visitors and vendors as required, directing them to the appropriate person as needed.

·Troubleshoot any office issues and escalate to the appropriate teams as needed.

·Coordinate with the Facilities team to manage all ongoing facilities-related issues, including maintenance requests submitted by employees, cleanliness of the office space, as well as landlord relations.

·Manage facility service coordination: office supplies, vendors, non-lab equipment, space planning, and office expansion efforts.

·Develop and manage relationships with catering sites for weekly lunches and events.

·Maintain an effective file organization for administrative projects and office files that are accessible to the team if needed.

·Ensure office and operations security by maintaining the security access database, file keys, access cards, and office keys

·Provide human resources support and miscellaneous administrative project support as necessary, ex: monitoring on boarding of new employees to ensure a positive employee experience

·Sort and distribute incoming mail to the appropriate recipients

·Event planning as needed.

Qualifications:

·Bachelor's degree Preferred

·At least 2-4 years’ experience in a life sciences environment preferred

· Proficiency in Windows operating systems, Outlook, Word, Excel, and general office equipment

· Ability to multitask with several priorities and maintain a high standard of discretion and confidentiality

·Excellent communication and interpersonal skills

· Flexible, confident, and driven toward results

· Ability to work with minimal supervision

-6 month contract

-Pay: $28/hr

Night Shift (4:30pm – 4:45am, Thu – Sat [rotating Wed])

Position Description

The Manufacturing Technician is responsible for the aseptic manufacturing of tissue-based (human and porcine) products for the regenerative market. This position involves operating simple processing equipment and manual handling of tissue to transform it into a finished product for our customers. To ensure product quality, this role much adhere to standard procedures and cGMP (Current Good Manufacturing Practices).

Main Areas of Responsibilities

• Works in a cleanroom or regulated area to process human and/or porcine tissue

• Adheres to standard operating procedures and cGMP

• Operates simple processing equipment including, but not limited to: heat sealers, biohazard laminar flow hoods, and mixers

• Monitors the quality of pre-packaged finished goods during production

• Records information on batch records, equipment and cleaning logs, and other documents.

• Uses computers, barcode scanners, and SAP to enter data and generate reports

• Maintains inventory of processing supplies

• Responsible for the sanitization of the facility

Qualifications

The below skills are attributes that may not be mandatory but are desired in the ideal candidate.

• High school diploma or equivalent required

• Minimum 1-2 years of related manufacturing experience, preferred

• Must have willingness to learn all equipment and jobs in the assigned processing area

• Ability to maintain a safe working environment and practice safe working habits

• Demonstrated attention to detail and adherence to procedures

• Demonstrated oral and written communication, critical thinking, arithmetic and proper business etiquette skills

• Must be willing and able to work with potentially biohazardous materials, including cadaveric tissue

• Ability to work in a cleanroom environment with proper gowning attire

• Ability to lift up to 30 pounds of boxes and materials off racks

• The position involves frequently sitting, walking, reaching, stooping, squatting, crouching, kneeling, crawling and stair climbing and has the ability to use fine motor skills to operate equipment and or machinery

Portsmouth, NH

12-month contract, potential for extension or conversion

Nights - 7PM - 7AM

The Manufacturing Associate is responsible for the manufacturing of therapeutic proteins (API) under cGMP conditions. Associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, sampling, and conduct routine sanitization tasks to maintain facility and equipment. They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique in handling of products and materials.

• Set up, operate equipment, and monitor production processes, including clean-in-place (CIP) and steam-in-place (SIP) operations and report production in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), review documentation as appropriate.

• Attain qualification for all assigned tasks and maintain individual training plan.

• Perform basic laboratory tasks, such as monitor pH, conductivity, test product samples, etc.

• Perform material movements, transfer raw materials, chemicals into, out of, across the production areas.

• Maintain facility and equipment through routine cleaning and sanitization, support 6S programs. Must be willing to gown and work in a "clean room" environment.

Administrative tasks - attending shift exchange, meetings, sending/receiving emails, participating in projects.

• Perform other duties as assigned.

Strong knowledge of Quality Assurance principles within the pharmaceutical/biotech industry, including GxP regulations and QMS processes.

The Opportunity: Project Manager GxP Quality Assurance

• Coordinate and lead cross-functional Quality projects, including QA process improvement and enhancement initiatives, to ensure alignment with business objectives and delivery against established timelines.
• Contribute to the planning and execution of strategic initiatives within the GxP Quality Assurance function to strengthen operational effectiveness and compliance.
• Coordinate and facilitate quality & cross-functional meetings, including agenda development, documentation of key decisions, and tracking action items through completion.
• Develop and maintain comprehensive project documentation, including project timelines, risk registers, action item trackers, dashboards, and status reports to ensure transparency and accountability.
• Identify project risks, gaps, and process inefficiencies, and proactively facilitate mitigation strategies to ensure compliance, operational continuity, and successful project outcomes.
• Coordinate inspection and commercial readiness activities from the Quality team to support organizational objectives, including global expansion.

Required Skills, Experience and Education:

• Strong project planning, scheduling, and resource management skills.
• Excellent communication and presentation skills, with ability to present to senior leadership.
• Strong stakeholder engagement and alignment skills.
• Experience with developing clear, visually compelling PowerPoint presentations with strong narrative flow and impactful visuals.
• Experience working in Pharmaceutical, biotech companies and partnering with key stakeholders including Regulatory, Clinical, CMC, Manufacturing, and IT.
• Knowledge of Quality Assurance principles within the pharmaceutical/biotech industry, including GxP regulations and QMS processes

Preferred Skills:

• Strong analytical skills with ability to interpret quality metrics and identify trends and risks.
• Strong leadership, problem-solving, and organizational skills.
• Ability to work effectively in a fast-paced, cross-functional, and regulated environment.

Job Summary

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

Essential Functions

• Inspects components, products and/or processes to ensure conformance with standards.
• Executes laboratory procedures for sample preparation.
• Independently performs materials analysis of substantial variety & complexity using ARx test methods, compendia methods, specifications.
• Ensure all analytical operations comply with cGMPs & ARx procedures and all laboratory experiments are properly documented in notebook and are in accord with regulatory requirements.
• Conducts method qualification, validation projects work from established documents using basic analytical techniques.
• Participates in the execution of validated test method transfer protocols; drafts & independently executes protocols.
• Recommends / initiates modifications of existing quality or production standards to achieve optimum quality with the equipment’s capability.
• Works independently to accomplish same and assists management in prioritization as needed.
• Conducts investigation of out-of-specification (OOS) or out-of-trend (OOT) results.
• Trains and/or mentors lower level chemists.
• Specializes and acts as lead expert in particular areas of quality control (e.g. methods, method development, statistical process control, etc.).
• Abide by the ARx Laboratory Chemical Hygiene Plan and other safety policies.Maintains a safe and clean work environment, notifying the supervisor of unsafe practices, conditions, or acts; takes on increasing responsibility for surfacing and implementing improved safety practices.
• Responsible for following all applicable waste handling procedures.

Additional Responsibilities

• Completes required paperwork / documentation accurately, neatly and in a timely manner.
• Effectively communicates with other associates, supervisors and various co-workers; relays information to the next shift (as needed); voluntarily assists other associates; communicates effectively to prevent problems from occurring.
• Interacts with and/or participates on cross-functional product development teams.
• Responsible for the proper disposal of hazardous waste into the proper labeled containers and drums.
• Make identifiable and substantial contributions to continuous improvement. Performs all duties consistent with established ARx guideline consistent with all regulatory requirements. Actively complies with and endorses Department and Company objectives.
• Performs other duties and responsibilities as assigned.

Job Specifications

• Requires a Bachelors (or higher) degree in Chemistry or closely related discipline (Analytical Chemistry preferred) plus a minimum of 5 years related experience.
• Knowledgeable and proficient in application of gas chromatography (headspace, high-pressure liquid & gel permeation), UV-VIS-FTIR spectroscopy, TOC, thermal and mechanical analysis (e.g. DMA, DSC, etc.); wet chemistry techniques desired.
• Mastery knowledge and understanding of scientific principles involved in the performance of analytical test methods.
• Ability to troubleshoot and perform basic maintenance to ensure optimum performance of instrumentation.
• Evidence of continuing education such as professional certification (i.e., ASQC) or college level courses related to the position.
• Ability to efficiently utilize time (coordinate several assignments concurrently).
• Ability to read and interpret documents such as test methods and procedure manuals.
• Knowledge of requirements for maintaining proper laboratory otebook documentation.
• Must have above average computer skills and knowledge; specifically in the operational use of analytical equipment have a computer interface.
• Ability to perform basic mathematical & statistical functions; capable of designing and drafting test method transfer protocols as well as executing same and writing related reports.
• Ability to apply basic statistical process control concepts such as control charting.
• Good communication skills (verbal and written).
• Excellent interpersonal skills.
• Requires common physical characteristics and abilities, such as above average agility and dexterity; physical exertion such as long periods of standing, recurring bending, crouching, stooping, stretching, reaching or similar activities should be expected.
• Work environment involves moderate risks or discomforts requiring special safety precautions, will be required to use personal protective equipment.

Sr. Associate

Thousand Oaks, CA (Onsite)

1 Year Initial Contract

Pay: $26/hr

Job Details: To perform experiments, organize data and analyze results under minimal supervision. With minimal supervision, plans, conducts or monitors experiments, records and organizes data, analyses results, generates robust and reliable data and/or Ensures that contracted studies are conducted in compliance with the respective protocol and applicable guidelines and regulations. Responsibilities include:

? Monitors or follows established experimental design and protocols and performs routine tasks and studies to obtain reproducible and reliable results with limited supervision

? Plans, monitors or conducts, analyzes and records experiments, and provides interpretation of data

? Develops and implements new protocols with moderate review

? Engages coworkers in scientific discussions

? Communicates data and interpretation to work group

? Skilled at developing systems to ensure quality data

? Skilled and/or knowledgeable in the use of standard laboratory equipment and with one or more major laboratory instruments/techniques

? Effectively trouble-shoots equipment and experimental difficulties ? Contributes to internal/external reports, papers, presentations, regulatory documents, invention disclosure submissions and/or patents

? Participates in department-wide support efforts such as safety, recruiting and committees

? May train staff and/or supervise others

? Coordinates and organizes resources needed to complete the task

? Understands when to seek input and when to make independent judgments

Day to Day Responsibilities:

Lab-based position. Responsible for sample analysis with a variety of analytical techniques (LC, CE, particle analysis, compendial methods). Responsible for supporting the timely execution of process related experiments to enable tech transfers to manufacturing sites. Candidate will be required to document study/analysis execution and interpret/present results and conclusions. Participate in team/group meetings.

Requirements:

• Degree in Biology, Biochemistry or Analytical Chemistry or related field
• Experience in a Biopharmaceutical working environment
• Experience with typical bio characterization techniques such as liquid chromatography techniques, capillary electrophoresis including troubleshooting strongly preferred.
• Good interpersonal skills, the candidate will be working in a very team-focused environment. Familiarity/experience with biologic process development.

Shift options: Hours are 2:00pm - 10:30pm, Hours are 10:00pm - 6:30am

Lab Analyst I

This position performs routine testing on all samples in the Analytical Services laboratory, providing analytical data for process control, quality control, process development, product development, and waste management. Employee will be required to work eight hours shifts, and rotating days within shift every three to four months. KC Quality Control lab is a 24 hours production site that operates on three shifts.

YOUR TASKS AND RESPONSIBILITIES

• Perform routine analytical testing as directed by protocols and work instructions.

• Work a variety of shifts (including weekends and holidays).

• Request additional work to increase team productivity.

• Prepare solutions, clean glassware, dispose of solid/liquid waste and other duties to help in the overall operations of the laboratory.

• Train others on waste management.

• Alert lab leadership of issues or discrepancies involving sample integrity, supply inventory, safety concerns, or analysis irregularities.

• Communicate troubleshooting opportunities in testing processes.

• Perform routine analytical testing as directed by protocols and work instructions.

• Work a variety of shifts (including weekends and holidays).

• Request additional work to increase team productivity.

• Conduct basic (operational) preventative maintenance according to work instructions. Identify and communicate operational issues of laboratory instruments and equipment KPIs Understand and operate Laboratory Information Management System (LIMS), Chromatography Data System (CDS) system, and other instrument specific computer systems.

• Search various databases for test methods, specifications, and standards to locate information required to complete analyses.

• Promptly and accurately record, calculate and report analytical results.

• Review analytical data and various LIMS reports.

• Communicate and discuss any issues with team members and supervisor.

• Complete data entry for metrics and KPIs Identify process improvement ideas and communicate opportunities.

• Assist in improving established procedures and implementing continuous improvement projects.

• Communicate testing results to customers as required; act with customers in mind. Notify leads when supplies/consumables are at critical levels.

• Observe good safety and housekeeping practices.

• Participate in lab/site safety programs and cross site initiatives.

• Maintain knowledgeable of RCRA hazardous waste regulations, waste determinations, waste codes, and how to immediately communicate discovery of spills and leaks

Required Qualifications:

• High school diploma + a minimum of 1-year lab experience

• Good oral and written communication skills.

• High attention to details and an ability to analyze outcomes against a standard.

• Ability to diagnose the typical instrument problems with little or no assistance and provide assistance to others.

• Ability to multitask and prioritize workload to optimize efficiency and productivity of the laboratory.

Preferred Qualifications:

• 3+ years laboratory experience

• Understands basic HPLC and GC operation.

Duties:

Document Technician: The main responsibilities are: Conduct a file review in the retention warehouse (Chicago Records). Provide a daily report about the case file reviewed. Conduct and verify the inventory of record cases by Department. Participate in follow-up meeting to review these results.

Skills:

Applies acquired knowledge and skills to complete standard tasks Readily learns and applies new information and methods to work in assigned area Maintains appropriate licenses, training and certifications Works on routine assignments that require some problem resolution Works within clearly defined standard operating procedures and/or scientific methods Adheres to all quality guidelines Works under moderate degree of supervision Work typically involves regular review of output by work lead or supervisor Refers complex unusual problems to supervisor

Education:

HS Diploma, GED or equivalent experience, preferred 1-2 years experience in related field, preferred

Biotechnician – Conjugation

Duties:

Performs efficiency studies (assays) and pre-clinical exploratory safety studies. Performs testing of clinical, research and quality control proficiency; evaluates instruments. Evaluates and analyzes clinical research data. Coordinates activities of associates and investigators to ensure compliance with protocol and overall clinical objectives. Manages storage of research samples.

Skills:

Assays

Education:

Associates

Duties:

• Accurately picks (using RF gun), packs, stages, scales, and loads customer orders for external/internal movement and prepares all pertinent documentation.
• Monitors and maintains an adequate supply of operating supplies and informs Coach when supplies need to be ordered.
• Maintains / back fills their respective areas keeping the supplies available.
• Performs clean up and light maintenance duties to maintain a high standard of housekeeping. Drives housekeeping efforts in preparation of internal and external audits
• Actively participates in and completes all company training programs for Work Instructions (WI), Standard Operating Procedures (SOP), Company Policies, and Safety programs demonstrating learned knowledge on a daily basis.
• Actively participates in all Company and Departmental meetings, Performance Centers, etc.
• Performs cycle counts on a daily basis for their assigned area using RF gun and assists in reconciling discrepancies with Inventory Control.

Skills:

Required:

• Ability to learn and apply all relevant WIs, SOPs, and other regulatory requirements.
• Ability to read information and apply what was described in the reading material to situations which may contain several details or describe processes involving several steps.
• Ability to effectively communicate both verbally and in writing to peers and management.
• Must have reliable transportation as position requires working at warehousing facilities located at multiple sites.
• Ability to use computers to perform a variety of data-entry transactions, perform RF transactions and to retrieve information (procedures; safety,
• employment, and other information using a calculator.
• Demonstrated ability to perform basic math functions using a calculator (add, subtract, multiply, divide, rounding, etc.).
• Demonstrated high level of personal motivation and initiative and be able to work independently to complete daily tasks assigned.
• Ability to adapt and be flexible with daily work assignment changes as well as a continuously-improving work environment.
• Ability and willingness to maintain accurate and factual hard-copy and electronic records.
• Demonstrated ability and willingness to work and participate effectively in a team environment.
• Operate warehouse industrial material handling equipment as required including Pallet Jacks, Pallet Transfer, Shrink Bundler, Strapping Machines, Shrink Wrapper, Pallet Scales, Conveyor, etc.
• Ability and willingness to follow directions, as assigned by management, coaches, peers, or in written instructions.
• Attention to detail, safety, quality and customer requirements.
• Preferred: Familiarity with MS Office products (specifically Word, Outlook, and Excel) and SAP or equivalent systems.

PHYSICAL DEMANDS:

• Must regularly lift and/or move up to 20 pounds, frequently lift and/or move up to 40 pounds, and occasionally lift and/or move up to 60 pounds with assistance.

Education:

• High School diploma or GED
• 2 years GMP warehouse experience