Schott Pharma Jobs in Usa

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

-24 month contract, pay $34/hr

Job Summary:

Responsible for conducting research, development and manufacturing laboratory experimentation and other scientific activities to support Ventana projects. Exercises technical expertise and discretion in the design, execution and interpretation of experiments that contribute to project strategies. Prepares technical reports, summaries, protocols and quantitative analyses. Presents and discusses results of experiments within department and project team. Maintains high level of professional expertise through familiarity with scientific literature and may participate in conferences and professional societies. Follows company policies and procedures for GMP, GLP, Design Control and others as appropriate. Maintains complete and accurate laboratory documentation and electronic files. May act as principal investigator in conducting own experiments

Responsibilities:

• Designs a wide range of experimental protocols.

• Executes bench experiments; makes detailed and general observations and analyzes data.

• Prepares technical reports, summaries and quantitative analyses.

• Maintains complete and accurate records.

• Normally receives general directions on routine and new assignments.

• Identifies and implements improvements to work processes and laboratory environment.

• Recognized expert for area of expertise.

• Recognizes and documents activities for publication and/or patent potential.

• Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.

• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

• Participates in cross functional technical teams such as a failure investigation or core team.

• Works well in a team environment by being a productive project team member, suggesting creative solutions to problems and providing input to project planning.

• Establishes interfaces across other organizational groups.

• Trains others in areas of expertise.

• Troubleshoots problems and institutes corrective action.

• Prepares and presents experimental procedures and results in group and project teams.

• Monitors work to ensure quality and continuously promote Quality First Time.

• Other duties as assigned by management.

Education:

Bachelor's in science required with 4+ years of experience

Skills:

• Knows wide range of experimental techniques and skilled in their applications.

• Capable with searching scientific literature to gain general and specific information.

• Skilled with use of word processing, spreadsheets, graphical and presentation software applications.

top 3-5 skills, experience or education required for this position:

1. Customer facing / communication skills

2. Time / work management

3. Basic knowledge of laboratory equipment

Job Title : Lab Coordinator

The Laboratory Coordinator will develop and administer various laboratory equipment support functions throughout R&D sites. This position involves serving as liaison among internal personnel as well as external organizations, to aid in equipment selection, purchasing (equipment and services), onboarding, calibration/service/repair, and decommissioning. These functions will be executed with consideration for laboratory needs, as well as quality and cost effectiveness of internal and external service providers.

Responsibilities :

• Interface with vendors, OEM, and internal service organizations to address laboratory equipment service needs.

• Assist R&D personnel with selection and purchase of laboratory equipment and services.

• Provide administrative support throughout equipment lifecycle (onboarding, maintenance/repair, decommissioning).

• Serve as liaison to on-site vendor service personnel.

• Receive incoming work request and generate workorders on demand.

• Process work orders and contracts within IBM Maximo system to ensure equipment status, service activities, and all cost of ownership expenses are properly documented.

• Maintain equipment warranty and service contract data within Maximo system and Access database.

• Process service contract renewals, including review of equipment reliability histories, determination of insourcing potential, and overall assessment of cost benefits.

• Work with department leadership to develop and refine processes in support of department functions.

Qualifications :

• College Degree or equivalent experience. A technical degree (Engineering or Science) is preferred.

• Knowledge of basic regulatory requirements, laboratory safety, and GxP.

• At least 2+ years of experience with a variety of laboratory equipment, either having served as a lab analyst, lab equipment service provider, or both.

• Effective written and oral communication skills capable of accommodating a diverse audience.

• Proficient in data entry, analysis, and presentation, particularly within Maximo, Cognos, and SAP environments.

• Attention to detail, strong organization and planning skills.

• Capable of independently developing creative solutions in a fast-paced environment.

• Self-motivated and positive attitude with a great desire to contribute to our success.

Associate Scientist

100% Onsite - Thousand Oaks, CA

3 Year Initial Contract

Pay: $30-31/hr

Schedule: Mon-Fri, 7am - 3 pm

JOB DESCRIPTION

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

* Effectively transfers experimental methods from literature to the lab and makes modifications as necessary

* 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

Ideal Candidate: Someone ready for heavy lab work. Minimum of Bachelors' degree & 3 YOE. Degree Analytical Chemistry, or Biochemistry. experience in a Biopharmaceutical working environment. Someone early in their career. Candidate with Commitment to time and energy. Has a great sense of urgency. Team player. Liquid Chromatography (LC) High-Performance Liquid Chromatography (HPLC)

Basic Qualifications

Masters degree OR Bachelors degree and 2 years of experience OR Associate’s degree and 4 years of experience OR High school diploma / GED and 6 years of experience

***Must Have***

Basic wet lab skills

Chromatography

Purification

JOB OVERVIEW

Reporting to the Sr. Manager, EHS, the EHS Associate position supports all areas of Environment, Health, and Safety with a focus on waste management, emergency response programs, and regulatory compliance.

PRIMARY RESPONSIBILITIES

• Demonstrate environmental, health, and safety (EHS) expertise while fostering a culture of safety excellence and proactive commitment to workplace well-being.
• Drives conformance to the site’s EHS management system
• Establish effective programs, communications, and procedures that meet regulatory requirements and align with Piramal EHS Guidelines.
• Manage waste and recycling programs in accordance with DEP, DOT, RCRA, and EPA requirements through internal procedures, training, and coordination of vendors.
• Provide support for sitewide EHS leading and lagging indicator programs, with a drive to CAPA completion and achievement of EHS sitewide and corporate goals.
• Identify and assess workplace hazards, implementing necessary measures to minimize risks.
• Sustain Occupational Health programs both in-house and contracted.
• Perform periodic workplace inspections, audits and hazard assessments.
• Keep site emergency response procedures up to date, conduct training and drills.
• Participate and foster growth in Site Safety Committee.
• Support ESG and sustainability goals.
• Maintain personal protective equipment (PPE) hazard assessment program and inventories.
• Demonstrate financial stewardship.

QUALIFICATIONS/REQUIREMENTS

• Minimum of Associated Degree, Bachelor’s preferred, in a scientific discipline, Health and Safety or Environmental Science preferred, with 3-5 years experience in the EHS field.
• Experience in hazardous and non-hazardous waste management.
• Solid understanding of OSHA regulations with training development and delivery competency.
• Working knowledge of spill response and management techniques.
• Must possess problem solving, logic, and critical thinking skills and the ability to make sound, risk-based decisions.
• Must be able to work in a team environment with effective project planning/management, organization, and execution skills.
• Must have proficiency in the Microsoft Office Suite programs.
• Excellent oral and written communication skills.
• Ability to work effectively managing multiple projects independently with cross-functional departments and manage priorities to meet timelines.
• Must be innovative, proactive, resourceful and committed to continuous improvement.

WORK ENVIRONMENT

The position requires the ability to work in office and manufacturing settings with time spent performing “on the floor” activities in laboratory and manufacturing areas, as well as outdoor activities such as water sampling and roof inspections. Generally a day shift position, but may require very occasional overtime, evening, or weekend work with an ability to be reached after hours in case of emergency.

PHYSICAL REQUIREMENTS

• Lift up to 40 lbs.
• Able to work safely with heavy equipment.
• Regularly stand, walk, sit, use hands and fingers, feel objects, tools, controls, reach with hand and arms, talk, hear, and good vision.
• Ability to climb ladders, bend, stoop, and kneel.
• Individual may be required to wear Personal Protection Equipment including N95 respirators and Powered Air Purifying Respirators.
• Not allergic to chemicals or bio-substances found in laboratory or production facilities.